Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT04695769
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2020-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C000604171', 'term': 'velpatasvir'}, {'id': 'C000619503', 'term': 'voxilaprevir'}, {'id': 'C000654129', 'term': 'sofosbuvir velpatasvir voxilaprevir drug combination'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2020-12-24', 'studyFirstSubmitQcDate': '2021-01-03', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of sustained virological response (SVR)', 'timeFrame': '12 weeks post treatment', 'description': 'Percentage of patients with Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) SVR12 is defined as HCV RNA \\< the lower limit of quantitation 12 weeks following the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Tolerability', 'timeFrame': 'During 12 weeks of treatment', 'description': 'Tolerability assessment by reporting any adverse events in addition to laboratory abnormalities via continuous monitoring of CBC, transaminases, serum bilirubin, and serum creatinine at baseline and every 4 weeks during treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCV', 'Relapse', 'treatment failure'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '37088312', 'type': 'DERIVED', 'citation': 'El-Kassas M, Emadeldeen M, Hassany M, Esmat G, Gomaa AA, El-Raey F, Congly SE, Liu H, Lee SS. A randomized-controlled trial of SOF/VEL/VOX with or without ribavirin for retreatment of chronic hepatitis C. J Hepatol. 2023 Aug;79(2):314-320. doi: 10.1016/j.jhep.2023.04.011. Epub 2023 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the role of ribavirin as an adjuvant to sofosbuvir/velpatasvir/voxilaprevir combination in retreatment of chronic hepatitis C with previous treatment failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥ 18 years) patients with chronic hepatitis C and detectable HCV RNA by Polymerase Chain Reaction (PCR) after completion of previous direct-acting antiviral regimen, and eligible for antiviral treatment.\n\nExclusion Criteria:\n\n* Patients with decompensated cirrhosis (Child-Pugh score B and C).\n* Patients with platelet count less than 50000/ mm³.\n* Patients with HCC or extrahepatic malignancy.\n* Pregnancy or inability to use an effective contraceptive method.'}, 'identificationModule': {'nctId': 'NCT04695769', 'briefTitle': 'Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HelwanU 76-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: SOF/VEL/VOX with RBV', 'description': 'Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily) plus Ribavirin (weight-based dose 1000 or 1200 mg daily according to patient body weight: \\< or \\> 60 kg).\n\nAnother name: Vosevi, RBV', 'interventionNames': ['Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: SOF/VEL/VOX', 'description': 'Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily).\n\nAnother name: Vosevi', 'interventionNames': ['Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]']}], 'interventions': [{'name': 'Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin', 'type': 'DRUG', 'otherNames': ['Vosevi + RBV'], 'description': 'Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.', 'armGroupLabels': ['Group A: SOF/VEL/VOX with RBV']}, {'name': 'Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]', 'type': 'DRUG', 'otherNames': ['Vosevi'], 'description': 'Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.', 'armGroupLabels': ['Group B: SOF/VEL/VOX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine Helwan University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hepato-gastroenterology specialist', 'investigatorFullName': 'Mohammed Emadeldeen', 'investigatorAffiliation': 'Helwan University'}}}}