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Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

NCT03619837 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-03-03

Study results available
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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.

Conditions

  • Hepatitis C
  • Transplantation Disease Transmission

Interventions

DRUG

Sofosbuvir/Velpatasvir

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

DRUG

Sofosbuvir/Velpatasvir/Voxilaprevir

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

Sponsors & Collaborators

Principal Investigators

  • Claus Niemann, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-15
Primary Completion
2019-12-21
Completion
2020-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619837 on ClinicalTrials.gov