Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-01-03 @ 8:35 PM
Study NCT ID:
NCT02781727
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D005183', 'term': 'Failure to Thrive'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ADS@ascendispharma.com', 'phone': '+1 650 352 8389', 'title': 'Aimee D Shu, MD', 'organization': 'Ascendis Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)', 'description': "All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.", 'eventGroups': [{'id': 'EG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 81, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 39, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Secondary hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Height Velocity at 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'OG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}], 'classes': [{'categories': [{'measurements': [{'value': '11.17', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '10.31', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0088', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is based on a test of superiority', 'groupDescription': 'ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable; treatment and gender as factors; and baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.', 'statisticalMethod': 'ANCOVA with multiple imputation', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'two-sided', 'nonInferiorityComment': 'Non-inferiority comparison with a non-inferiority margin of 2 cm/year, followed by a test of superiority if non-inferiority is established.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '52 weeks', 'description': 'Annualized height velocity (AHV) at 52 weeks for weekly lonapegsomatropin (TransCon hGH) and daily hGH treatment groups', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'OG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs related to study drug', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SAEs related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': 'Number of participants with Treatment-Emergent Adverse Events for the weekly lonapegsomatropin and daily hGH treatment groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all randomized subjects who had received at least 1 dose of active treatment.'}, {'type': 'SECONDARY', 'title': 'Annualized Height Velocity Over 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'OG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'Week 5', 'categories': [{'measurements': [{'value': '13.54', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '12.83', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '13.28', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '12.22', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '12.65', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '11.21', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'categories': [{'measurements': [{'value': '11.89', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '10.90', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '11.17', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '10.31', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 5, Week 13, Week 26, Week 39 and Week 52', 'description': 'Annualized height velocity (AHV) over 52 weeks for weekly lonapegsomatropin and daily hGH treatment groups. AHV by visit was determined by ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable, treatment and gender as factors, baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.'}, {'type': 'SECONDARY', 'title': 'Change in Height Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'OG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'Week 5', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 5, Week 13, Week 26, Week 39 and Week 52', 'description': 'Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height SDS was derived using the LMS method as ((Height/M)\\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from 2000 CDC growth charts for the United States. A Standard Deviation Score of 0 represents the population mean. A higher change from baseline in Height Standard Deviation Score (SDS) indicates a better outcome. The change from baseline in height SDS by visit was determined by ANCOVA model and included baseline age, peak GH levels (log transformed) at stimulation test and baseline height SDS as covariates, as well as treatment and gender as factors.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.'}, {'type': 'SECONDARY', 'title': 'Average IGF-1 Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'OG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}], 'classes': [{'title': 'Week 13', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 13, Week 26, Week 39, and Week 52', 'description': 'IGF-1 Standard Deviation Score (SDS) is the number of standard deviations above or below the mean Insulin-like Growth Factor 1 (IGF-1) level for age and sex. IGF-1 SDS was derived using the LMS method as ((IGF-1/M)\\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from Bidlingmaier et al. (2014). A Standard Deviation Score of 0 represents the population mean. Average IGF-1 SDS by visit was determined by ANCOVA. The ANCOVA model included baseline age, peak GH levels (log transformed) at stimulation test, baseline IGF-1 SDS as covariates, as well as treatment and gender as factors. Modeled values begin at Week 13 corresponding with achievement of IGF-1 steady state. Average IGF-1 SDS values by visit for the Lonapegsomatropin group were derived from a population pharmacodynamic model; the average IGF-1 SDS values for the Genotropin group are represented by observed values.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Anti-hGH Binding Antibody Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'OG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Start of study treatment through Week 52', 'description': 'Number of participants with treatment emergent anti-hGH binding antibody formation during the 52 week study. All samples were negative for anti-hGH neutralizing antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all randomized subjects who had received at least 1 dose of active treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'FG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}], 'periods': [{'title': 'Pre-dosing Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '106 subjects were randomized to the lonapegsomatropin arm, but 1 subject withdrew consent before receiving the first dose of study drug.', 'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lonapegsomatropin', 'description': 'Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)'}, {'id': 'BG001', 'title': 'Daily hGH', 'description': 'Once daily subcutaneous injection of Genotropin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, Categorical', 'categories': [{'title': '<6 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': '≥6 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '112.93', 'spread': '14.09', 'groupId': 'BG000'}, {'value': '112.15', 'spread': '15.29', 'groupId': 'BG001'}, {'value': '112.66', 'spread': '14.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height SDS', 'classes': [{'categories': [{'measurements': [{'value': '-2.89', 'spread': '0.85', 'groupId': 'BG000'}, {'value': '-3.00', 'spread': '0.90', 'groupId': 'BG001'}, {'value': '-2.93', 'spread': '0.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height SDS was derived using the LMS method as ((Height/M)\\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from 2000 CDC growth charts for the United States. A Standard Deviation Score of 0 represents the population mean.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '21.01', 'spread': '6.54', 'groupId': 'BG000'}, {'value': '21.20', 'spread': '6.67', 'groupId': 'BG001'}, {'value': '21.08', 'spread': '6.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '16.06', 'spread': '1.78', 'groupId': 'BG000'}, {'value': '16.46', 'spread': '2.17', 'groupId': 'BG001'}, {'value': '16.20', 'spread': '1.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI SDS', 'classes': [{'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.95', 'groupId': 'BG000'}, {'value': '-0.14', 'spread': '1.07', 'groupId': 'BG001'}, {'value': '-0.25', 'spread': '0.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI Standard Deviation Score (SDS) is the number of standard deviations above or below the mean body mass index for age and sex. BMI SDS was derived using the LMS method as ((BMI/M)\\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from 2000 CDC growth charts for the United States. A Standard Deviation Score of 0 represents the population mean.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'IGF-1 SDS', 'classes': [{'categories': [{'measurements': [{'value': '-2.08', 'spread': '0.88', 'groupId': 'BG000'}, {'value': '-1.96', 'spread': '0.98', 'groupId': 'BG001'}, {'value': '-2.04', 'spread': '0.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'IGF-1 Standard Deviation Score (SDS) is the number of standard deviations above or below the mean Insulin-like Growth Factor 1 (IGF-1) level for age and sex. IGF-1 SDS was derived using the LMS method as ((IGF-1/M)\\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from Bidlingmaier et al. (2014). A Standard Deviation Score of 0 represents the population mean.', 'unitOfMeasure': 'standard deviation score', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-12', 'size': 1396806, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-24T14:34', 'hasProtocol': True}, {'date': '2019-02-19', 'size': 1088077, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-24T14:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'dispFirstSubmitDate': '2019-12-17', 'completionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-06', 'studyFirstSubmitDate': '2016-05-19', 'dispFirstSubmitQcDate': '2019-12-17', 'resultsFirstSubmitDate': '2021-09-24', 'studyFirstSubmitQcDate': '2016-05-20', 'dispFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-06', 'studyFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Height Velocity at 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'timeFrame': '52 weeks', 'description': 'Annualized height velocity (AHV) at 52 weeks for weekly lonapegsomatropin (TransCon hGH) and daily hGH treatment groups'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '52 Weeks', 'description': 'Number of participants with Treatment-Emergent Adverse Events for the weekly lonapegsomatropin and daily hGH treatment groups'}, {'measure': 'Annualized Height Velocity Over 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'timeFrame': 'Week 5, Week 13, Week 26, Week 39 and Week 52', 'description': 'Annualized height velocity (AHV) over 52 weeks for weekly lonapegsomatropin and daily hGH treatment groups. AHV by visit was determined by ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable, treatment and gender as factors, baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.'}, {'measure': 'Change in Height Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'timeFrame': 'Week 5, Week 13, Week 26, Week 39 and Week 52', 'description': 'Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height SDS was derived using the LMS method as ((Height/M)\\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from 2000 CDC growth charts for the United States. A Standard Deviation Score of 0 represents the population mean. A higher change from baseline in Height Standard Deviation Score (SDS) indicates a better outcome. The change from baseline in height SDS by visit was determined by ANCOVA model and included baseline age, peak GH levels (log transformed) at stimulation test and baseline height SDS as covariates, as well as treatment and gender as factors.'}, {'measure': 'Average IGF-1 Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups', 'timeFrame': 'Week 13, Week 26, Week 39, and Week 52', 'description': 'IGF-1 Standard Deviation Score (SDS) is the number of standard deviations above or below the mean Insulin-like Growth Factor 1 (IGF-1) level for age and sex. IGF-1 SDS was derived using the LMS method as ((IGF-1/M)\\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from Bidlingmaier et al. (2014). A Standard Deviation Score of 0 represents the population mean. Average IGF-1 SDS by visit was determined by ANCOVA. The ANCOVA model included baseline age, peak GH levels (log transformed) at stimulation test, baseline IGF-1 SDS as covariates, as well as treatment and gender as factors. Modeled values begin at Week 13 corresponding with achievement of IGF-1 steady state. Average IGF-1 SDS values by visit for the Lonapegsomatropin group were derived from a population pharmacodynamic model; the average IGF-1 SDS values for the Genotropin group are represented by observed values.'}, {'measure': 'Number of Participants With Treatment Emergent Anti-hGH Binding Antibody Formation', 'timeFrame': 'Start of study treatment through Week 52', 'description': 'Number of participants with treatment emergent anti-hGH binding antibody formation during the 52 week study. All samples were negative for anti-hGH neutralizing antibodies.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human Growth Hormone', 'hGH', 'GHD', 'rHGH', 'Pediatric Growth Hormone Deficiency', 'Long Acting Growth Hormone', 'Somatropin', 'Prodrug', 'Growth Failure', 'Growth Hormone Replacement Therapy', 'Sustained Release', 'Sustained Release Growth Hormone', 'Growth Hormone Deficiency'], 'conditions': ['Growth Hormone Deficiency, Pediatric', 'hGH (Human Growth Hormone)', 'Endocrine System Diseases', 'Hormones', 'Pituitary Diseases']}, 'referencesModule': {'references': [{'pmid': '34272849', 'type': 'DERIVED', 'citation': 'Thornton PS, Maniatis AK, Aghajanova E, Chertok E, Vlachopapadopoulou E, Lin Z, Song W, Christoffersen ED, Breinholt VM, Kovalenko T, Giorgadze E, Korpal-Szczyrska M, Hofman PL, Karpf DB, Shu AD, Beckert M. Weekly Lonapegsomatropin in Treatment-Naive Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial. J Clin Endocrinol Metab. 2021 Oct 21;106(11):3184-3195. doi: 10.1210/clinem/dgab529.'}]}, 'descriptionModule': {'briefSummary': 'A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females) with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH : Genotropin). This is a global trial that will be conducted in Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prepubertal children with GHD (either isolated or as part of a multiple pituitary hormone deficiency) in Tanner stage 1 (Tanner 1982) aged:\n\n * Boys: 3-12 years, inclusive\n * Girls: 3-11 years, inclusive\n* Impaired height (HT) defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS ≤ -2.0) according to the 2000 CDC Growth Charts for the United States Methods and Development, available at http://www.cdc.gov/growthcharts/\n* Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay\n* Bone age (BA) at least 6 months less than chronological age\n* Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤-1)\n* Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is able to read, understand, and sign)\n\nExclusion Criteria:\n\n* Children with a body weight below 12 kg\n* Prior exposure to recombinant hGH or IGF-1 therapy\n* Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast) at Screening (MRI results from up to 6 months prior to Screening may be accepted)\n* Children with psychosocial dwarfism\n* Children with idiopathic short stature\n* History or presence of malignant disease; any evidence of present tumor growth\n* Closed epiphyses\n* Major medical conditions and/or presence of contraindication to hGH treatment\n* Participation in any other trial of an investigational agent within 3 months prior to Screening'}, 'identificationModule': {'nctId': 'NCT02781727', 'briefTitle': 'A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascendis Pharma A/S'}, 'officialTitle': 'A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)', 'orgStudyIdInfo': {'id': 'TransCon hGH CT-301'}, 'secondaryIdInfos': [{'id': '2016-001145-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TransCon hGH', 'description': 'Once weekly subcutaneous injection of TransCon hGH', 'interventionNames': ['Drug: Once weekly subcutaneous injection of TransCon hGH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'human growth hormone (Genotropin)', 'description': 'Once daily subcutaneous injection of Genotropin', 'interventionNames': ['Drug: Once daily subcutaneous injection of Genotropin']}], 'interventions': [{'name': 'Once weekly subcutaneous injection of TransCon hGH', 'type': 'DRUG', 'description': 'Once weekly subcutaneous injection', 'armGroupLabels': ['TransCon hGH']}, {'name': 'Once daily subcutaneous injection of Genotropin', 'type': 'DRUG', 'description': 'Once daily subcutaneous injection', 'armGroupLabels': ['human growth hormone (Genotropin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '0075', 'city': 'Yerevan', 'country': 'Armenia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'zip': '3168', 'city': 'Clayton', 'country': 'Australia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '220020', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '0144', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0162', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '1023', 'city': 'Grafton', 'country': 'New Zealand', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Ascendis Pharma Investigatonal Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '02-691', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '700111', 'city': 'Iași', 'country': 'Romania', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '426009', 'city': 'Izhevsk', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '420138', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '620022', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '125373', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127994', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603136', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630048', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '644001', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '191144', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194100', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443079', 'city': 'Samara', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410054', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '634050', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '450008', 'city': 'Ufa', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '160022', 'city': 'Vologda', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 59.2239, 'lon': 39.88398}}, {'zip': '394024', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '38039', 'city': 'Melikgazi', 'country': 'Turkey (Türkiye)', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 38.72455, 'lon': 36.21708}}, {'zip': '61080', 'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}, {'zip': '61093', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '01021', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04114', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '65031', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Ascendis Pharma Investigational Site', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}], 'overallOfficials': [{'name': 'Michael Beckert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ascendis Pharma A/S'}, {'name': 'Aimee D Shu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ascendis Pharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascendis Pharma Endocrinology Division A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}