An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

ClinicalTrials.gov ID: NCT02165189

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Official title

A Phase 2 Open-Label Study in Patients With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant to Explore the Safety And Efficacy of Simeprevir and Sofosbuvir With and Without Ribavirin

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus (HCV) Genotype 1 infection.

Study identification

NCT ID: NCT02165189
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Janssen Scientific Affairs, LLC; Industry
Enrollment: 46 participants

Conditions and interventions

Conditions

Hepatitits C

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2014 (Type not available)
Primary completion: Nov 2015 (Actual)
Completion: Nov 2015 (Actual)
Last update posted: Nov 11, 2016

2014 – 2015

United States locations

U.S. sites: 11
U.S. states: 8
U.S. cities: 11

Facility	City	State	ZIP	Site status
Not listed	Aurora	Colorado	—	—
Not listed	Gainesville	Florida	—	—
Not listed	Miami	Florida	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Ann Arbor	Michigan	—	—
Not listed	Detroit	Michigan	—	—
Not listed	New York	New York	—	—
Not listed	Durham	North Carolina	—	—
Not listed	Philadelphia	Pennsylvania	—	—
Not listed	Pittsburgh	Pennsylvania	—	—
Not listed	Dallas	Texas	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02165189, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 11, 2016 · Synced Nov 15, 2026