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Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01468584
First received: November 2, 2011
Last updated: October 29, 2014
Last verified: October 2014
Results First Received: October 29, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: MP-424 (generic name:Telaprevir)
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

MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks

Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks

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


Participant Flow:   Overall Study
    MP-424  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  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
MP-424

MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks

Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks

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


Baseline Measures
    MP-424  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean ± Standard Deviation
  56.8  ± 6.7  
Gender  
[units: participants]
 
Female     2  
Male     8  



  Outcome Measures

1.  Primary:   Undetectable HCV 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: NCT01468584     History of Changes
Other Study ID Numbers: G060-A11
Study First Received: November 2, 2011
Results First Received: October 29, 2014
Last Updated: October 29, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare