CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 122 enrolled
Drug / intervention
Sofosbuvir/Velpatasvir +1 moredrug
Likely dose
Sofosbuvir/Velpatasvir/Voxilaprevir 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03619837
NCT03619837Phase 4Completed
CompareCT.gov

PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver

University of California, San Francisco·interventional·Posted Aug 8, 2018·Updated Mar 3, 2021

In Brief

A Phase 4 clinical trial evaluating Sofosbuvir/Velpatasvir and Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C and Transplantation Disease Transmission. Completed, enrolled 122 participants across 6 sites.

Detailed Summary

In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Transplantation Disease Transmission
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 8, 2018
Enrollment StartJul 15, 2018
Primary CompletionDec 21, 2019
Study CompletionAug 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.9 years ago

Interventions

Sofosbuvir/Velpatasvirdrug

Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.

Sofosbuvir/Velpatasvir/Voxilaprevirdrug

Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir. Dosage: 400mg/100mg/100mg daily for 12 weeks.