Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-27 @ 11:18 AM
Study NCT ID:
NCT02526420
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2015-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Versartis International Trial in Adults With Long-Acting Growth Hormone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], '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': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams', 'timeFrame': '5 months', 'description': 'Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.'}, {'measure': 'Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )', 'timeFrame': '5 months', 'description': 'To evaluate the starting doses of VRS-317 for each cohort as measured by the proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval (one month after the first dose)'}, {'measure': 'Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)', 'timeFrame': '5 months', 'description': 'To evaluate the dose titration plan of VRS-317 for each cohort as measured by the proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers', 'timeFrame': '5 months', 'description': 'To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers'}, {'measure': 'Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)', 'timeFrame': '5 months', 'description': 'To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VRS-317', 'Long Acting Growth Hormone', 'Versartis', 'somavaratan', 'Growth Hormone Deficiency', 'Adult Growth Hormone Deficiency', 'AGHD', 'Growth Hormone Replacement', 'Growth Hormone Replacement Therapy', 'XTEN'], 'conditions': ['Adult Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.', 'detailedDescription': "A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing regimen in adults with GHD. This is an open-label, international, multicenter study with VRS-317 treatment for five months. This treatment period will include monthly dose titrations until a subject's mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on sensitivity to rhGH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female subjects of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods\n* Subjects must have documented GHD during adulthood.\n* Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months.\n* Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months.\n* Subjects receiving daily rhGH injections must washout for 14 days.\n* Subjects must provide signed informed consent.\n* Subjects must have a BMI (kg/m2) between 19.0 and 35.0.\n\nExclusion Criteria:\n\n* Subjects with diabetes mellitus or inadequate glucose control\n* Subjects with untreated adrenal insufficiency.\n* Subjects with free thyroxine outside the normal reference range.\n* Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies.\n* Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class \\> 2.\n* Subjects with current significant cerebrovascular, pulmonary, neurological, renal, inflammatory, or hepatobiliary disease.\n* Subjects with current papilledema.\n* Subjects with a history of persistent or recurring migraines.\n* Subjects with current edema (≥ CTCAE Grade 2).\n* Subjects with current drug or alcohol abuse.\n* Subjects with a documented history of HIV, current HBV or HCV infection\n* Subjects with a prior history of malignancy excluding adequately treated non-melanoma skin cancers or in situ carcinoma of the cervix.\n* Women who are pregnant or breastfeeding.\n* Subjects with a significant abnormality in Screening laboratory results"}, 'identificationModule': {'nctId': 'NCT02526420', 'acronym': 'VITAL', 'briefTitle': 'Versartis International Trial in Adults With Long-Acting Growth Hormone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aravive, Inc.'}, 'officialTitle': 'An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)', 'orgStudyIdInfo': {'id': '15VR7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A: Somavaratan in Older Adults', 'description': 'Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \\>= 35 years of age', 'interventionNames': ['Drug: somavaratan']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B: Somavaratan in Younger Adults', 'description': 'Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \\< 35 years of age', 'interventionNames': ['Drug: somavaratan']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C: Somavaratan in Women on Estrogen', 'description': 'Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)', 'interventionNames': ['Drug: somavaratan']}], 'interventions': [{'name': 'somavaratan', 'type': 'DRUG', 'otherNames': ['VRS-317'], 'description': 'Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly', 'armGroupLabels': ['Cohort A: Somavaratan in Older Adults', 'Cohort B: Somavaratan in Younger Adults', 'Cohort C: Somavaratan in Women on Estrogen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute Inc.', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutic Research Institute of Orange County', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Research Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Endocrine Associates of Dallas', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite-Universitätsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D- 45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Birmingham', 'state': 'B152gw', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'state': 'EC1M 6BQ', 'country': 'United Kingdom', 'facility': 'William Harvey Research Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Hull, East Yorkshire', 'state': 'HU3 2RW', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Manchester', 'state': 'M20 4BX', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Daniela Rogoff, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Versartis Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versartis Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Premier Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}