Clinical Trial Details
| Trial ID: | L0652 |
| Source ID: | NCT04075916 |
| Associated Drug: | Epclusa |
| Title: | A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients |
| Acronym: | THINKER-NEXT |
| Status: | ACTIVE_NOT_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | End Stage Renal Disease |
| Interventions: | DRUG: Epclusa |
| Outcome Measures: | Primary: Post-treatment sustained virologic response (SVR) to direct-acting antiviral (DAA), The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR-12; negative HCV RNA 12 weeks after completing Epclusa therapy)/(number of subjects treated with Epclusa post-kidney transplantation), Baseline to 24 weeks | |
| Sponsor/Collaborators: | Sponsor: University of Pennsylvania | Collaborators: Gilead Sciences|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 201 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2021-06-22 |
| Completion Date: | 2026-01-05 |
| Results First Posted: | |
| Last Update Posted: | 2025-01-10 |
| Locations: | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|University of Florida, Gainesville, Florida, 32608, United States|Jackson Memorial Hospital/University of Miami, Miami, Florida, 33136, United States|Johns Hopkins, Baltimore, Maryland, 21287, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|New York Presbyterian Hospital/Columbia University, New York, New York, 10032, United States|University of Cincinnati, Cincinnati, Ohio, 45267, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Vanderbilt University, Nashville, Tennessee, 37235, United States |
| URL: | https://clinicaltrials.gov/show/NCT04075916 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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