TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 vs. placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in treatment-naïve, genotype 1 hepatitis C-infected subjects - Quest 1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020444-36-GB

Enrollment

375

Registered

2010-12-06

Start date

2011-02-14

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus (HCV) in treatment naïve patients MedDRA version: 14.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 10022891 - Investigations

Interventions

Product Name: TMC435 Product Code: TMC435 (R494617 or JNJ-38733214-AAA, G007) Pharmaceutical Form: Capsule, hard INN or Proposed INN: simeprevir CAS Number: 923604-59-5 Current Sponsor code: TMC435 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

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). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of TMC435 versus placebo as part of a treatment regimen including peginterferon alfa-2a (PegIFNa-2a) and ribavirin (RBV), with respect to the proportion of subjects with sustained virologic response (SVR) 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: - Secondary Objectives: Reference is made to section 2 (Objectives) on page(s) 27 and 28 of the Clinical Trial Protocol - Exploratory Objectives: Reference is made to section 2 (Objectives) on page(s) 27 and 28 of the Clinical Trial Protocol;Primary end point(s): The proportion of patients with a sustained virologic response (SVR) 12 weeks after the planned end of treatment;Timepoint(s) of evaluation of this end point: 12 weeks after planned end of treatment	—

Measure

Time frame

Main Objective: To demonstrate the superiority of TMC435 versus placebo as part of a treatment regimen including peginterferon alfa-2a (PegIFNa-2a) and ribavirin (RBV), with respect to the proportion of subjects with sustained virologic response (SVR) 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: - Secondary Objectives: Reference is made to section 2 (Objectives) on page(s) 27 and 28 of the Clinical Trial Protocol - Exploratory Objectives: Reference is made to section 2 (Objectives) on page(s) 27 and 28 of the Clinical Trial Protocol;Primary end point(s): The proportion of patients with a sustained virologic response (SVR) 12 weeks after the planned end of treatment;Timepoint(s) of evaluation of this end point: 12 weeks after planned end of treatment

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Secondary

Measure	Time frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -	—

Countries

Australia, Canada, Germany, Israel, Italy, Mexico, Netherlands, New Zealand, Romania, Russian Federation, Spain, Ukraine, United Kingdom, United States

Contacts

Public ContactJanssen Biologics BV

Janssen-Cilag International NV - Clinical Registry Group

ClinicalTrialsEU@its.jnj.com+31071524 21 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026