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)

NCT ID: NCT01852604

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-04-30

Brief 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.

Detailed Description

Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.

Conditions

Chronic Hepatitis C Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV

Part A: Participants with genotype 1b or 4 received samatasvir 50 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Samatasvir matching placebo

Intervention Type: OTHER

Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.

Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV

Part A: Participants with genotype 1b or 4 received samatasvir 100 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Samatasvir matching placebo

Intervention Type: OTHER

Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.

Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV

Part A: Participants with genotype 1b or 4 received samatasvir 150 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV

Part B: Participants with genotype 1b or 4 received samatasvir 25 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV

Part B: Participants with genotype 1b or 4 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Part B: GT 6 - samatasvir 100/simeprevir/RBV

Part B: Participants with Genotype 6 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV

Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

TMC647055

Intervention Type: DRUG

TMC647055 will be supplied as 150 mg oral capsules.

Ritonavir (RTV)

Intervention Type: DRUG

Ritonavir will be supplied as 80 mg/mL oral solution.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV

Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Group Type: EXPERIMENTAL

Samatasvir

Intervention Type: DRUG

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

TMC647055

Intervention Type: DRUG

TMC647055 will be supplied as 150 mg oral capsules.

Ritonavir (RTV)

Intervention Type: DRUG

Ritonavir will be supplied as 80 mg/mL oral solution.

Pegylated interferon (Peg-IFN)

Intervention Type: BIOLOGICAL

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Interventions

Samatasvir

Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.

Intervention Type: DRUG

Simeprevir

Simeprevir will be supplied as 75 and 150 mg oral capsules.

Intervention Type: DRUG

Ribavirin (RBV)

Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Intervention Type: DRUG

TMC647055

TMC647055 will be supplied as 150 mg oral capsules.

Intervention Type: DRUG

Ritonavir (RTV)

Ritonavir will be supplied as 80 mg/mL oral solution.

Intervention Type: DRUG

Pegylated interferon (Peg-IFN)

Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.

Intervention Type: BIOLOGICAL

Samatasvir matching placebo

Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

IDX-06A-005

Identifier Type: OTHER

Identifier Source: secondary_id

1894-005

Identifier Type: -

Identifier Source: org_study_id