Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-04-13 @ 10:17 PM
Study NCT ID:
NCT02410356
Status:
TERMINATED
Last Update Posted:
2021-12-10
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Brazil', 'Bulgaria', 'Canada', 'Chile', 'Croatia', 'France', 'Georgia', 'Germany', 'Israel', 'Lithuania', 'Mexico', 'Peru', 'Poland', 'Romania', 'Russia', 'Serbia', 'Slovenia', 'Sweden', 'Turkey (Türkiye)', 'Ukraine']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629490', 'term': 'albusomatropin'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'dispFirstSubmitDate': '2018-04-16', 'completionDateStruct': {'date': '2016-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2015-03-30', 'dispFirstSubmitQcDate': '2018-04-16', 'studyFirstSubmitQcDate': '2015-04-01', 'dispFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with adverse events', 'timeFrame': '48 weeks', 'description': 'Safety of TV-1106 compared to reference drug'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score', 'timeFrame': 'Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* males and females 18 years of age or over\n* diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection\n* treated with a stable dose of daily rhGH for at least 3 months prior to screening\n* stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening\n\n * Other criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator\n* Presence of contraindications to rhGH treatment\n* patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening\n* patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year\n* patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening\n* presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past year.\n* patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%\n* patients using weight reducing agents or appetite suppressants\n\n * Other criteria apply, please contact the investigator for more information"}, 'identificationModule': {'nctId': 'NCT02410356', 'briefTitle': 'Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency', 'orgStudyIdInfo': {'id': 'TV1106-IMM-30022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TV-1106', 'description': 'TV-1106 to be injected once weekly.', 'interventionNames': ['Drug: TV-1106']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dGH', 'description': 'dGH to be given as daily injections.', 'interventionNames': ['Drug: dGH']}], 'interventions': [{'name': 'TV-1106', 'type': 'DRUG', 'otherNames': ['rhGH'], 'description': 'The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.', 'armGroupLabels': ['TV-1106']}, {'name': 'dGH', 'type': 'DRUG', 'otherNames': ['rhGH', 'Somatropin'], 'description': 'The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.', 'armGroupLabels': ['dGH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13137', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '33155-6541', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13166', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13165', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13155', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Teva Investigational Site 13158', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13162', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33030', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13136', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13138', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33130', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13152', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33145', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13161', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155-6541', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13500', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13503', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13148', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13134', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13129', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Teva Investigational Site 13135', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Teva Investigational Site 13146', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Teva Investigational Site 13147', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13143', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13502', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13140', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 13128', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 13142', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '76014', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13144', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '75218', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13163', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13130', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77084', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13141', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13154', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 13159', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98003', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 13504', 'geoPoint': {'lat': 47.32232, 'lon': -122.31262}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 13164', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 13157', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Teva Investigational Site 33035', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54118', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '708 00', 'city': 'Moravskoslezsky', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54119'}, {'zip': '304 60', 'city': 'Plzensky', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54116'}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Teva Investigational Site 63059', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Chaïdári', 'country': 'Greece', 'facility': 'Teva Investigational Site 63058', 'geoPoint': {'lat': 38.01135, 'lon': 23.66597}}, {'city': 'Ioannina', 'country': 'Greece', 'facility': 'Teva Investigational Site 63060', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'zip': '1062', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Teva Investigational Site 51202', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Teva Investigational Site 51206', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Teva Investigational Site 51205', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Teva Investigational Site 51204', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Teva Investigational Site 51208', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '5000', 'city': 'Szolnok', 'country': 'Hungary', 'facility': 'Teva Investigational Site 51207', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': '25018', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Teva Investigational Site 30129', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '034 91', 'city': 'Ľubochňa', 'country': 'Slovakia', 'facility': 'Teva Investigational Site 62041', 'geoPoint': {'lat': 49.12011, 'lon': 19.16891}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Teva Investigational Site 31129', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Teva Investigational Site 31121', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28805', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Teva Investigational Site 31125', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}