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Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00780910
First Posted: October 28, 2008
Last Update Posted: May 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
Results First Submitted: June 5, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: MP-424
Drug: Ribavirin
Drug: Peginterferon Alfa-2b

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MP-424

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks


Participant Flow:   Overall Study
    MP-424
STARTED   109 
COMPLETED   107 
NOT COMPLETED   2 
Adverse Event                2 



  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.
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Reporting Groups
  Description
MP-424

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks


Baseline Measures
   MP-424 
Overall Participants Analyzed 
[Units: Participants]
 109 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.4  (8.6) 
Gender 
[Units: Participants]
 
Female   43 
Male   66 


  Outcome Measures

1.  Primary:   The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)   [ Time Frame: After 24 weeks of follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications of Results:

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00780910     History of Changes
Other Study ID Numbers: G060-A8
First Submitted: October 24, 2008
First Posted: October 28, 2008
Results First Submitted: June 5, 2012
Results First Posted: August 20, 2012
Last Update Posted: May 2, 2014