Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-02 @ 8:18 AM
Study NCT ID:
NCT01779518
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2014-01-16
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}], 'ancestors': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 3}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HCV', 'Sustained Virologic Response', 'Direct Acting Antiviral', 'GS-7977', 'Pegylated interferon', 'Ribavirin', 'Open Label', 'Sofosbuvir', 'Liver transplant', 'Hepatitis', 'Hepatitis, Chronic', 'Hepatitis C', 'Hepatitis C, Chronic', 'Liver Diseases', 'Digestive System Diseases', 'Hepatitis, Viral, Human', 'Virus Diseases', 'Enterovirus Infections', 'Picornaviridae Infections', 'RNA Virus Infections', 'Flaviviridae Infections', 'Antiviral Agents', 'Anti-Infective Agents', 'Therapeutic Uses', 'Pharmacologic Actions', 'Antimetabolites', 'Molecular Mechanisms of Pharmacological Action'], 'conditions': ['Post-transplant Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> or = 18 years\n* Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing\n* Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)\n* Life expectancy of \\< 12 months if the HCV is left untreated\n\nExclusion Criteria:\n\n* History of clinically significant drug allergy to nucleoside/nucleotide analogs\n* Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject\n* Unable or unwilling to follow the contraception requirements'}, 'identificationModule': {'nctId': 'NCT01779518', 'briefTitle': 'Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection', 'orgStudyIdInfo': {'id': 'GS-US-334-0139'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['GS-7977', 'PSI-7977', 'Sovaldi™']}, {'name': 'Ribavirin', 'type': 'DRUG'}, {'name': 'Pegylated Interferon', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}