Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-03-29 @ 3:39 AM
Study NCT ID:
NCT01949766
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2013-09-24
First Post:
2013-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535933', 'term': 'Cholestasis, progressive familial intrahepatic 1'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570223', 'term': 'glycerol phenylbutyrate'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2013-09', 'lastUpdateSubmitDate': '2013-09-20', 'studyFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2013-09-20', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Byler Disease']}, 'descriptionModule': {'briefSummary': 'This is a single patient compassionate use protocol to determine whether RAVICTI will improve bile flow in a subject who previously tolerated therapy with Buphenyl.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Byler Disease\n* Cholestasis\n* Tolerance of Buphenyl therapy\n\nExclusion Criteria:\n\n* Allergy/Hypersensitivity to RAVICTI'}, 'identificationModule': {'nctId': 'NCT01949766', 'briefTitle': 'Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease', 'orgStudyIdInfo': {'id': 'PRO12070385.2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Glycerol phenylbutyrate', 'type': 'DRUG', 'otherNames': ['RAVICTI']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}