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Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00780416
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : August 20, 2012
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE October 24, 2008
First Posted Date  ICMJE October 27, 2008
Results First Submitted Date  ICMJE June 5, 2012
Results First Posted Date  ICMJE August 20, 2012
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE November 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2008)
Undetectable HCV RNA at 24 weeks after completion of drug administration (SVR, sustained viral response) [ Time Frame: After 24 weeks of follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2008)
Adverse event, Adverse drug reaction [ Time Frame: throughout study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Official Title  ICMJE A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C
Brief Summary This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • 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
  • Drug: Ribavirin
    600 - 1000 mg/day based on body weight for 48 weeks
  • Drug: Peginterferon Alfa-2b
    1.5 mcg/kg/week for 48 weeks
Study Arms  ICMJE
  • Experimental: TRV/PEG/RBV
    Interventions:
    • Drug: MP-424
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa-2b
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa-2b
  • Active Comparator: PEG/RBV
    Interventions:
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa-2b
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa-2b
Publications * Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol. 2012 Jan;56(1):78-84. doi: 10.1016/j.jhep.2011.07.016. Epub 2011 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2012)
189
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2008)
165
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Genotype 1, chronic hepatitis C
  • Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
  • Able and willing to follow contraception requirements

Exclusion Criteria:

  • Cirrhosis of the liver or hepatic failure
  • Hepatitis B surface antigen-positive or HIV antibodies-positive
  • History of, or concurrent hepatocellular carcinoma
  • History of, or concurrent depression, schizophrenia; or suicide attempt in the past
  • Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00780416
Other Study ID Numbers  ICMJE G060-A6
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Vertex Pharmaceuticals Incorporated
Investigators  ICMJE
Principal Investigator: Fumitaka Suzuki, MD Department of Hepatology, Toranomon Hospital
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP