A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00630058
First received: February 24, 2008
Last updated: April 16, 2014
Last verified: April 2014
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Hepatitis C
Interventions: Drug: MP-424(H), PEG-IFN-a-2b, RBV
Drug: MP-424 (L), PEG-IFN-a-2b, 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
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
Group A (MP-424 High)

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 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Group B (MP-424 Low)

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks


Participant Flow:   Overall Study
    Group A (MP-424 High)     Group B (MP-424 Low)  
STARTED     10     10  
COMPLETED     6     6  
NOT COMPLETED     4     4  
Adverse Event                 1                 1  
Withdrawal by Subject                 0                 1  
stopping criteria                 3                 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
Group A (MP-424 High)

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 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Group B (MP-424 Low)

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Total Total of all reporting groups

Baseline Measures
    Group A (MP-424 High)     Group B (MP-424 Low)     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: years]
Mean ± Standard Deviation
  50.1  ± 6.8     54.3  ± 8.5     52.2  ± 7.8  
Gender  
[units: participants]
     
Female     4     6     10  
Male     6     4     10  



  Outcome Measures
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1.  Primary:   Cmax (Maximum Observed Concentration in Plasma) of MP-424   [ Time Frame: Data were collected at Day1 to Day85 ]

2.  Primary:   Tmax (Time of Maximum Concentration in Plasma) of MP-424   [ Time Frame: Data were collected at Day1 to Day85 ]

3.  Primary:   AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424   [ Time Frame: Data were collected at Day1 to Day85 ]

4.  Primary:   Ctrough (Minimum Observed Concentration in Plasma) of MP-424   [ Time Frame: Data were collected at Day1 to Day85 ]

5.  Primary:   T1/2(Time of Half-Life) of MP-424   [ Time Frame: Data were collected at Day1 to Day85 ]

6.  Secondary:   Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels   [ Time Frame: 37 weeks ]


  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: NCT00630058     History of Changes
Other Study ID Numbers: G060-A5
Study First Received: February 24, 2008
Results First Received: December 12, 2012
Last Updated: April 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare