An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Parti⦠(NCT02262728) | Clinical Trial Compass
CompletedPhase 2
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
United States40 participantsStarted 2014-09-30
Plain-language 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 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Co-infection with any HCV genotype
* Co-infection with human immunodeficiency virus (HIV)-1 or -2 ā¦
What they're measuring
1
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)