A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01292239
First received: February 1, 2011
Last updated: December 16, 2013
Last verified: December 2013
Results First Received: October 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Placebo
Drug: TMC435
Drug: Peginterferon alfa-2a (pegIFN alfa-2a)
Drug: Ribavirin (RBV)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 17-January-2011 and 22-October-2012 and recruited participants with chronic genotype 1 Hepatitis C Virus (HCV) infection who were treatment-naïve from 37 study centers in Japan. A total 183 participants were randomized and started treatment; 172 completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Treatment-naïve HCV-infected participants were assigned to 1 of 2 groups to receive TMC435 100 mg once daily with PegIFN alpha-2a and ribavirin (PR) until Week 12, followed by PR until Week 24 or 48 OR placebo with PR until Week 12, followed by PR until Week 48.

Reporting Groups
  Description
TMC435 100 mg 12 Wks + PR 24/48 Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
PBO 12 Wks + PR 48 Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).

Participant Flow:   Overall Study
    TMC435 100 mg 12 Wks + PR 24/48     PBO 12 Wks + PR 48  
STARTED     123     60  
COMPLETED     119     53  
NOT COMPLETED     4     7  
Not specified                 1                 1  
Withdrawal by Subject                 3                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TMC435 100 mg 12 Wks + PR 24/48 Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
PBO 12 Wks + PR 48 Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
Total Total of all reporting groups

Baseline Measures
    TMC435 100 mg 12 Wks + PR 24/48     PBO 12 Wks + PR 48     Total  
Number of Participants  
[units: participants]
  123     60     183  
Age  
[units: years]
Median ( Full Range )
  56  
  ( 23 to 69 )  
  54.5  
  ( 30 to 69 )  
  55  
  ( 23 to 69 )  
Gender  
[units: participants]
     
Female     84     36     120  
Male     39     24     63  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)   [ Time Frame: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60) ]

2.  Secondary:   The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)   [ Time Frame: EOT (up to Week 24 or 48) and 24 weeks after the after the last dose of treatment (up to Week 48 or 72) ]

3.  Secondary:   The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up   [ Time Frame: Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60, 72, EOT (up to Week 24 or 48), FU Week 4, 12, and 24 ]

4.  Secondary:   The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)   [ Time Frame: Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48) ]

5.  Secondary:   The Number of Participants With Viral Breakthrough   [ Time Frame: Up to EOT (up to Week 24 or 48) ]

6.  Secondary:   The Number of Participants Demonstrating Viral Relapse   [ Time Frame: Up to Week 72 ]

7.  Secondary:   The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)   [ Time Frame: Baseline (Day 1) to EOT (up to Week 24 or 48) ]

8.  Secondary:   The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24   [ Time Frame: Week 24 ]

9.  Secondary:   Plasma Concentrations of TMC435   [ Time Frame: Overall (ie, Up to Week 12) ]

10.  Secondary:   Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435   [ Time Frame: Overall (Up to Week 12) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Director
Organization: Janssen Pharmaceutical K.K., Japan
phone: 81 3 44115639


No publications provided


Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01292239     History of Changes
Other Study ID Numbers: CR017686, TMC435HPC3003
Study First Received: February 1, 2011
Results First Received: October 15, 2013
Last Updated: December 16, 2013
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
Japan: Pharmaceuticals and Medical Devices Agency