Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT02705534
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2016-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C586541', 'term': 'ledipasvir'}, {'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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sustained viral response rate', 'timeFrame': 'week 24 (12 weeks after end of treatment)', 'description': 'Qualitative polymerase chain reaction assay for Hepatitis C RNA'}], 'secondaryOutcomes': [{'measure': 'Adverse drug events', 'timeFrame': 'week 2, 4, 8, 12, 24', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Cirrhosis', 'Sofosbuvir', 'Ledipasvir', 'Ribavirin'], 'conditions': ['Hepatitis C', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if \\<75 kg, 1200 mg/d if \\>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.', 'detailedDescription': 'Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of care. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current recommendation for cirrhotics (genotype 1) is SOF/LDV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/LDV/RBV the investigators decided to treat 50 HCV genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score \\> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Positive qualitative hepatitis C RNA polymerase chain reaction assay on two occasions at least 6 months apart\n\nExclusion Criteria:\n\n* Renal failure \\[estimated glomerular filtration rate (eGFR) \\< 30 cc/min\\],\n* Model or End stage Liver Disease (MELD) score \\> 20,\n* Child's class C (score \\> 12),\n* Heart rate \\< 50/min,\n* Taking amiodarone"}, 'identificationModule': {'nctId': 'NCT02705534', 'acronym': 'SL50', 'briefTitle': 'Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin', 'orgStudyIdInfo': {'id': '94-04-37-31023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects will receive sofosbuvir, ledipasvir and ribavirin', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ledipasvir', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['SOF'], 'description': '400 mg, included in a combination pill with 90 mg ledipasvir', 'armGroupLabels': ['Treatment']}, {'name': 'Ledipasvir', 'type': 'DRUG', 'otherNames': ['LDV'], 'description': '90 mg, included in a combination pill with 400 mg sofosbuvir', 'armGroupLabels': ['Treatment']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['RBV'], 'description': '1000 mg/day if \\<75 kg, 1200 mg/day for \\>75 kg. Divided into two daily doses', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14117', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Shariati Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Reza Malekzadeh, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bakhtar Bioshimi Co', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}