Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00778518
Status:
COMPLETED
Last Update Posted:
2009-10-12
First Post:
2008-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-09', 'studyFirstSubmitDate': '2008-10-22', 'studyFirstSubmitQcDate': '2008-10-22', 'lastUpdatePostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temporal profiling of circulating IGF-1 levels.', 'timeFrame': '3 period'}], 'secondaryOutcomes': [{'measure': 'Body composition measurements at start of study and end of study', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['growth hormone', 'growth hormone deficiency', 'GHD', 'PEG', 'pegylated', 'IGF-1'], 'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).', 'detailedDescription': 'The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 years old\n* GHD of childhood onset\n* completed growth\n* IGF-1 \\<=2SDS\n* rhGH treatment naive\n* hGH levels below cut-off\n\nExclusion Criteria:\n\n* History of malignancy or intracranial tumors\n* ECG abnormality\n* ICH\n* hepatic dysfunction\n* renal impairment\n* major medical conditions\n* inadequate T4\n* positive for HBV, HCV, or HIV\n* alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT00778518', 'briefTitle': 'Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ambrx, Inc.'}, 'officialTitle': 'Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).', 'orgStudyIdInfo': {'id': 'PRO-ARX201-701'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2007-001746-40'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'low dose', 'interventionNames': ['Drug: ARX201']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Medium dose', 'interventionNames': ['Drug: ARX201']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'High Dose', 'interventionNames': ['Drug: ARX201']}], 'interventions': [{'name': 'ARX201', 'type': 'DRUG', 'description': 'Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.', 'armGroupLabels': ['1']}, {'name': 'ARX201', 'type': 'DRUG', 'description': 'Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.', 'armGroupLabels': ['2']}, {'name': 'ARX201', 'type': 'DRUG', 'description': 'Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Budapest', 'country': 'Hungary', 'facility': 'Accelsiors CRO and Consultancy Services', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Mihaly Juhasz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Accelsiors CRO & Consultancy Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ambrx, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono International SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Douglas W. Axelrod, MD, PhD, Sr. Vice President', 'oldOrganization': 'Clinical Research and Development, Ambrx, Inc.'}}}}