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 22, 2013
Last verified: October 2013

November 2, 2011
October 22, 2013
November 2011
September 2013   (final data collection date for primary outcome measure)
Undetectable HCV RNA at 24 weeks after completion of drug administration (SVR, sustained viral response) [ Time Frame: week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01468584 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Subjects With Genotype 2 Hepatitis C, Who Did Not Respond to Previous Treatment

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous treatment.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: MP-424 (generic name:Telaprevir)
    750mg q8h for 12 weeks
  • Drug: Ribavirin
    400 - 1000 mg/day based on body weight for 24 weeks
  • Drug: Peginterferon alfa-2b
    1.5mcg/kg/week for 24 weeks
Experimental: MP-424
Interventions:
  • Drug: MP-424 (generic name:Telaprevir)
  • Drug: Ribavirin
  • Drug: Peginterferon alfa-2b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Genotype 2, chronic hepatitis C
  • Non-responders (patient who did not respond to previous treatment)
  • 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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01468584
G060-A11
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
October 2013

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