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Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

Study acronym: PREVENT-HCV
StatusRecruiting
PhaseNot applicable
Started2023-04-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from Johns Hopkins University

Amendment history

2026-09-02
Study Status, Contacts/Locations v6
Primary completion pushed: 2026-09 → 2027-09
Completion pushed: 2027-03 → 2028-03
Study sitesdetails revised at 1 of 9 sites
2026-02-13
Study Status, Contacts/Locations v5
Study sites7→9
2025-02-07
Study Status, Eligibility, Contacts/Locations v4
Primary completion date2025-09→2026-09
Study sites6→7
Eligibility criteria-72 characters
[...] n (detectable HCV RNA) at time of screening. Participant has a Fibrosis-4 (FIB-4) score ≥ 3.25 at time of screening, or a history of cirrhosis or advanced liver fibrosis. Participant's asparta [...]
2024-04-15
Study Status, Eligibility, Contacts/Locations v3
Eligibility criteria+6 characters
[...] pant is ≥ 18 years old. Exclusion Criteria: Participant has aactive historyHCV infection (detectable HCV RNA) at time of HCV, defined as being HCV antibody positivescreening. Participant has a Fibrosis-4 (FIB-4) score ≥ 13.4525 at time of screening, or a history of cirrhosis or advanced [...]
Study sites6 entries, revised
Ochsner Medical Center Methodist University Hopsitalof California San Diego University of Wisconsin, Madison
2023-04-20
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04→confirmed 2023-04-19
Eligibility criteria+24 characters
[...] years old. Exclusion Criteria: Participant has a history of priorHCV, ordefined activeas being HCV antibody positive. Participant has a Fibrosis-4 (FIB-4) score ≥ 1.45 at time [...]
Secondary endpoints11 entries, revised
Incidence and severity of bacterial, fungal, viral, and other opportunistic infections
Study sitesdetails revised at 6 of 6 sites
2023-03-09
Study Status v1
Start date2023-03→2023-04
2022-12-06
Original filing
This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups: Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks. Arm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.
Trial Details
NCT Number NCT05653232
Lead Sponsor Johns Hopkins University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions HCV
Enrollment 120 participants
Start Date 2023-04-19
Primary Completion 2027-09 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-04