Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 insuf...
Detailed Description
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 tre...
Eligibility Criteria
Inclusion
- Documented chronic Hepatitis C virus (HCV) infection: diagnosis of HCV more than (\>) 6 months before the Screening visit, either by detectable HCV ribonucleic acid (RNA), a HCV positive antibody or the presence of histological changes consistent with chronic hepatitis
- HCV genotype 1 or 4 infection and HCV RNA plasma level \>10,000 international unit per milliliter (IU/mL) (both determined at screening)
- Presence of cirrhosis, which is defined as a FibroScan with a result of \>14.5 kilopascals (kPa) at Screening
- HCV treatment-naive participants: participant has not received treatment with any approved or investigational drug for the treatment of HCV infection and HCV treatment-experienced participants: participant has had at least 1 documented previous course of a non-direct-acting antiviral agent (DAA), interferon (IFN)-based HCV therapy (with or without Ribavirin \[RBV\]). Last dose in this previous course should have occurred at least 2 months prior to Screening
- Decompensated liver disease: Panel 1: Child Pugh A (mild hepatic impairment) with evidence of portal hypertension \[confirmed by the presence of esophageal varices on gastroscopy or hepatic venous pressure gradient (HVPG) greater than or equal to (\>=) 10 millimeter of mercury (mm Hg)\], Panel 2: Child-Pugh B (moderate hepatic impairment) 7 to 9 (extremes included)
Exclusion
- Co-infection with any HCV genotype
- Co-infection with human immunodeficiency virus (HIV)-1 or -2 (positive HIV-1 or HIV-2 antibodies test at Screening)
- Co-infection with hepatitis B virus (hepatitis B surface antigen \[HBsAg\] positive)
- Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the Investigator
- Use of any disallowed therapies before the planned first dose of study drugs
Key Trial Info
Start Date :
September 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02262728
Start Date
September 30 2014
End Date
April 25 2018
Last Update
February 4 2025
Active Locations (1)
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1
San Antonio, Texas, United States