Recruiting HCV Clinical Trial: Simeprevir, Daclatasvir and Sofosbuvir Genotype 1 or 4 and Decompensated Liver Disease

Related: Medivir: Simeprevir, Sofosbuvir and Daclatasvir Phase II IMPACT Study Initiated to Treat Genotype 1 and 4 Hepatitis C Patients

IMPACT Phase II study for chronic hepatitis C Is Now Recruiting In Texas
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Hepatitis C, Chronic
Phase 2
Drug: Simeprevir
Drug: Daclatasvir
Drug: Sofosbuvir
ClinicalTrials.gov Identifier:
NCT02262728

Purpose

The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver) C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of study drug treatment (SVR12).

This is an open-label (all people know which treatment the participants receive) Phase 2 study to investigate the efficacy, safety and pharmacokinetics of simeprevir, daclatasvir and sofosbuvir in treatment-naive (participants have never received HCV treatment with any approved or investigational agent) and treatment - experienced (participants have failed at least one previous course of [Pegylated] interferon [(Peg)IFN], with or without Ribavirin) participants. The total study duration for each participant will be approximately 276 weeks. The study will consist of 3 parts: Screening Phase (approximately 4 weeks) and open-label treatment Phase (from Week 4 to 16) and follow-up Phase (until 5 years after the actual end of study drug treatment). Participants will receive simeprevir (150 milligram [mg] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks. Efficacy will be primarily evaluated by percentage of participants with SVR12. Participants' safety will be monitored throughout the study.

Estimated Enrollment: 40

Locations

United States, Texas

Recruiting
San Antonio, Texas, United States

Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

questions: JNJ.CT@sylogent.com