Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT01784718
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2013-02-06
First Post:
2013-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buphenyl Therapy for Byler's 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': 'C075773', 'term': '4-phenylbutyric acid'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2013-02', 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Byler Disease']}, 'descriptionModule': {'briefSummary': 'This is a single patient compassionate use protocol to determine whether Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Byler Disease\n* Cholestasis unresponsive to pharmacologic therapy\n\nExclusion Criteria:\n\n* Allergy/Hypersensitivity to Buphenyl'}, 'identificationModule': {'nctId': 'NCT01784718', 'briefTitle': "Buphenyl Therapy for Byler's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': "Compassionate Use of Buphenyl® in the Treatment of Byler's Disease", 'orgStudyIdInfo': {'id': 'PRO12070385'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Buphenyl', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}