A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Placebo; Drug: Mericitabine; Drug: Telaprevir; Drug: Ribavirin; Drug: Peginterferon Alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482390

2011-002715-28 (EudraCT Number)

NV27779

Details and patient eligibility

About

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C infection for at least 6 months duration
• Hepatitis C genotype 1a or 1b
• Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
• Participants showed a previous null response to therapy as defined by < 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion criteria

• Hepatitis C infection with a genotype other than genotype 1a or 1b
• Body mass index < 18 or >= 36 kilograms per square meters (kg/m^2)
• Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection
• Herbal remedies <=1 month prior to the first dose of study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)

Experimental group

Description:

Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks).

Treatment:

Drug: Peginterferon Alfa-2a

Drug: Mericitabine

Drug: Telaprevir

Drug: Ribavirin

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)

Experimental group

Description:

Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

Treatment:

Drug: Peginterferon Alfa-2a

Drug: Mericitabine

Drug: Telaprevir

Drug: Ribavirin

TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

Experimental group

Description:

Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

Treatment:

Drug: Peginterferon Alfa-2a

Drug: Placebo

Drug: Mericitabine

Drug: Telaprevir

Drug: Ribavirin

TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)

Active Comparator group

Description:

Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

Treatment:

Drug: Peginterferon Alfa-2a

Drug: Placebo

Drug: Telaprevir

Drug: Ribavirin