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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2010-020444-36-GB
• Date of registration: 06/12/2010
• Prospective Registration: Yes
• Primary sponsor: Janssen R&D Ireland
• Public title: TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
• Scientific title: 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
• Date of first enrolment: 14/02/2011
• Target sample size: 375
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020444-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Janssen Biologics BV
• Affiliation: Janssen-Cilag International NV - Clinical Registry Group

• Name: Janssen Biologics BV
• Affiliation: Janssen-Cilag International NV - Clinical Registry Group

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

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
Other descriptive name: R494617 or JNJ-38733214-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The proportion of patients with a sustained virologic response (SVR) 12 weeks after the planned end of treatment

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

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).

Timepoint(s) of evaluation of this end point: 12 weeks after planned end of treatment

Secondary Outcome(s)

Secondary end point(s): -

Timepoint(s) of evaluation of this end point: -

Secondary ID(s)

TMC435-TiDP16-C208

Source(s) of Monetary Support

Janssen R&D Ireland

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 20/03/2015
• Date Completed: 29/01/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-020444-36/results