Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants.

Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Janssen Research & Development, LLC
• Treatments: Interferons; Ribavirin; Ritonavir; Simeprevir

Criteria

Inclusion Criteria:

• Must have Genotype 1a, 1b, 4 or 6 HCV infection.

• Documented clinical history compatible with chronic hepatitis C

• HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C)

• Must agree to use an acceptable double method of birth control (one of which must be a barrier method) for at least 6 months after the last dose of study drugs.

Exclusion Criteria:

• Female participants who are pregnant or breastfeeding.

• Body Mass Index (BMI) > 36 kg/m2.

• Co-infected with hepatitis B virus or human immunodeficiency virus (HIV).

• History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.

• History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.

• Has one or more known primary or secondary causes of liver disease, other than hepatitis C

• History of, or active, acute or chronic, liver or biliary injury due to drugs, toxins, non-HCV viral hepatitis, gallstones or other etiologies

• Donated blood or had significant blood loss 30 days prior to dosing