TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin Therapy

A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFNa-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFNa and ribavirin therapy. - ATTAIN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001180-53-GB

Enrollment

744

Registered

2012-02-14

Start date

2012-03-12

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Hepatitis C Virus (HCV) genotype-1 infection MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: JNJ-38733214-AAA - capsule, hard (G019) Product Code: TMC435 (or R494617) Pharmaceutical Form: Capsule, hard INN or Proposed INN: simeprev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Genotype 1 hepatitis C infection (confirmed at screening) - A liver biopsy within 3 years before screening (or between the screening and baseline) is required, showing chronic hepatitis C infection. In case of contradicitions, alternative methods must be used to determine or confirm the stage of liver disease. - patient must have had at least 1 documented previous course of treament with PegINFa-2a or PegINFa-2b in combination with RBV (at least 12 weeks for null responder and 20 for partial responder) - Plasma HCV RNA of >10,000 IU/mL at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 728 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

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 - previous CHC treatment other than PegIFN and RBV - pregnant or planning to become pregnant

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the non-inferiority of TMC435 versus TVR, both given in combination with PegIFNa-2a and RBV, by less than 12%, with respect to the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: Reference is made to section 2.1 (Objectives), pages 42 and 43 of the Clinical Trial Protocol;Primary end point(s): The proportion of patients with sustained virological response 12 weeks after the planned end of treatment (SVR12);Timepoint(s) of evaluation of this end point: At Week 60	—

Measure

Time frame

Main Objective: To demonstrate the non-inferiority of TMC435 versus TVR, both given in combination with PegIFNa-2a and RBV, by less than 12%, with respect to the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: Reference is made to section 2.1 (Objectives), pages 42 and 43 of the Clinical Trial Protocol;Primary end point(s): The proportion of patients with sustained virological response 12 weeks after the planned end of treatment (SVR12);Timepoint(s) of evaluation of this end point: At Week 60

—

Secondary

Measure	Time frame
Secondary end point(s): The proportion of patients with sustained virological response 24 weeks after the planned end of treatment (SVR24);Timepoint(s) of evaluation of this end point: At Week 72	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactJanssen Biologics BV

Janssen-Cilag International NV - Clinical Registry Group

ClinicalTrialsEU@its.jnj.com+31071524 2166

Outcome results

None listed

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