An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients (QUEST-1)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: TMC435; Drug: Peginterferon alpha-2a (PegIFN alpha-2a); Drug: Placebo; Drug: Ribavirin (RBV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01289782

TMC435-TiDP16-C208 (Other Identifier)

CR017386

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.

Full description

This is a randomized, double-blind (neither physician nor participants know the name of the assigned drug), placebo-controlled study of TMC435 in participants who are infected with genotype 1 hepatitis C virus (HCV), who have never received treatment for HCV infection before. Participants in this study will also receive two other drugs for their HCV infection called peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV). The purpose of the study is to investigate if TMC435 is superior to placebo in reducing plasma levels of HCV ribonucleic acid (RNA) to an undetectable level 12 weeks after the end of treatment. For the first 12 weeks, participants will take either TMC435 or placebo, plus PegIFNα-2a and RBV. For the next 12 weeks, participants will take PegIFN alpha-2a and RBV only. After that, some participants will continue to take PegIFN alpha-2a and RBV for up to 24 additional weeks and some will stop taking PegIFN alpha-2a and RBV depending on response-guided treatment criteria. The study doctor will inform each participant about how to take their study medication and when they should stop taking it. After a participant stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. The total duration of the study is 78 weeks (including screening). Participants will be monitored for safety throughout the study.

Enrollment: 395 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Genotype 1 hepatitis C infection (confirmed at screening)
• Patient has not received any prior treatment for hepatitis C
• Patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
• Must agree to use 2 forms of effective contraception throughout study (both males and females)

Exclusion criteria

• Infection with HIV or non genotype 1 hepatitis C
• Liver disease not related to hepatitic C infection
• Hepatic decompensation
• Significant laboratory abnormalities or other active diseases
• Pregnant or planning to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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395 participants in 2 patient groups, including a placebo group

TMC435

Experimental group

Description:

TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 24 or 48 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: TMC435

Drug: Peginterferon alpha-2a (PegIFN alpha-2a)

Placebo

Placebo Comparator group

Description:

Placebo 150 mg capsule once daily for 12 weeks in addition to PegIFNα-2a and RBV for 48 weeks

Treatment:

Drug: Ribavirin (RBV)

Drug: Placebo

Drug: Peginterferon alpha-2a (PegIFN alpha-2a)