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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

NCT02165189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-11-11

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitits C

Interventions

DRUG

Simeprevir

Participants will be administered simeprevir capsule 150 mg orally once daily up to 12 weeks.

DRUG

Sofosbuvir

Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 12 weeks.

DRUG

Ribavirin

Participants will be administered ribavirin 2 x 200 mg tablets (for participants weighing less than 75 kilogram (\[kg\]) or 3 x 200 mg tablets (for participants weighing more than 75 kg) orally once daily up to 12 weeks.

DRUG

Simeprevir

Participants will be administered simeprevir capsule 150 mg orally once daily up to 24 weeks.

DRUG

Sofosbuvir

Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 24 weeks.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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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 NCT02165189 on ClinicalTrials.gov