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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT01290679
Date of registration:	07/01/2011
Prospective Registration:	Yes
Primary sponsor:	Janssen R&D Ireland
Public title:	An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants QUEST-2
Scientific title:	A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon a-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon a-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects
Date of first enrolment:	March 2011
Target sample size:	393
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01290679
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Argentina	Austria	Belgium	Brazil	Bulgaria	France	Germany	Korea, Republic of
Netherlands	Poland	Portugal	Puerto Rico	Russian Federation	Slovakia	Spain	Turkey
United States

Contacts

Name:	Janssen R&D Ireland Clinical Trial
Address:
Telephone:
Email:
Affiliation:	Janssen R&D Ireland

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: Placebo

Drug: TMC435

Drug: Ribavirin (RBV)

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

Primary Outcome(s)

The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) [Time Frame: Week 36 or Week 60]

Secondary Outcome(s)

Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [Time Frame: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48]

Percentage of Participants With On-treatment Failure [Time Frame: Week 48]

The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4 [Time Frame: Week 4]

The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR) [Time Frame: Week 12]

The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR) [Time Frame: Weeks 4 and 12]

Time From End-of-treatment to Viral Relapse [Time Frame: Up to Week 72]

Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL [Time Frame: Up to Week 48]

Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [Time Frame: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48]

Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment [Time Frame: Baseline to Week 60 and Week 72]

Percentage of Participants With Null Response [Time Frame: Week 12]

Percentage of Participants With On-treatment Virologic Response at All Time Points [Time Frame: Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42]

Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule [Time Frame: Week 24]

The Percentage of Participants Achieving a Early Virologic Response (EVR) [Time Frame: Week 12]

The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) [Time Frame: Week 48 or Week 72]

Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores [Time Frame: Baseline to Week 60 and Week 72]

The Percentage of Participants Achieving a Rapid Virologic Response (RVR) [Time Frame: Week 4]

Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable [Time Frame: Up to Week 48]

Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment [Time Frame: Baseline to Week 60 and Week 72]

Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4 [Time Frame: Week 4]

The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) [Time Frame: Up to Week 48]

The Percentage of Participants With Viral Breakthrough at Different Time Points [Time Frame: Up to Week 48]

Plasma Concentration of TMC435: Predose Plasma Concentration (C0h) [Time Frame: Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12]

Percentage of Participants With Viral Breakthrough [Time Frame: Up to Week 48]

The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) [Time Frame: Week 72]

Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL [Time Frame: Up to Week 48]

Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment [Time Frame: Baseline to Week 60 and Week 72]

Percentage of Participants With Viral Relapse [Time Frame: Up to Week 72]

Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) [Time Frame: At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12]

Plasma Concentration of TMC435: Systemic Clearance (CL) [Time Frame: At protocol-specified time points at Weeks 2, 4, 8, and 12]

Median Time to Normalization of Alanine Aminotransferase (ALT) Levels [Time Frame: Up to Week 48]

Percentage of Participants With Partial Response [Time Frame: Week 12]

The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4) [Time Frame: Week 28 or Week 52]

Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable [Time Frame: Up to Week 48]

Secondary ID(s)

TMC435-TiDP16-C216

2010-021174-11

CR017380

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	13/06/2014
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01290679

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