An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants (QUEST-2)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Placebo; Drug: Ribavirin (RBV); Drug: TMC435; Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01290679

2010-021174-11 (EudraCT Number)

TMC435-TiDP16-C216 (Other Identifier)

CR017380

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 alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

Full description

This is a randomized, double-blind (neither physician or participant knows the name of the assigned drug), placebo-controlled study of TMC435 in participants who are infected with genotype 1 hepatitis C virus who have never received treatment for this before. Participants in this study will also receive two other drugs for their infection (either peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®). The purpose of the study is to investigate if TMC435 is superior to placebo in reducing hepatitis C virus to an undetectable level 24 weeks after the end of treatment. For the first 12 weeks, participants will take TMC435 or placebo, plus peginterferon and ribavirin. For the next 12 weeks, participants will take peginterferon and ribavirin only. After that, some participants will continue to take peginterferon and ribavirin for up to 24 additional weeks. Other participants will stop taking peginterferon and ribavirin. 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. Study assessments at each study visit may include but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), participant questionnaires, and physical examinations. TMC435 will be taken as an oral capsule of 150 mg once per day. Peginterferon (Pegasys ®) will be given as an injection of 180 µg once each week. Peginterferon (PegIntron®) will be given as an injection once each week and the dose will depend on your body weight. Ribavirin will be taken as a tablet (Copegus ®) or a capsule (Rebetol ®) twice each day and the dose will depend on your body weight.

Enrollment: 393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Genotype 1 hepatitis C infection (confirmed at screening)
• Participant has not received any prior treatment for hepatitis C
• Participant 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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393 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 alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 24 or 48 weeks

Treatment:

Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)

Drug: Ribavirin (RBV)

Drug: TMC435

Placebo

Placebo Comparator group

Description:

Placebo 150 mg capsule once daily for 12 weeks in addition peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 48 weeks

Treatment:

Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)

Drug: Ribavirin (RBV)

Drug: Placebo