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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01468584
First received: November 2, 2011
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: MP-424 (generic name:Telaprevir)
Drug: Ribavirin
Drug: Peginterferon alfa-2b
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Undetectable HCV RNA at 24 weeks after completion of drug administration (SVR, sustained viral response) [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-424 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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468584

Locations
Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

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
Last Updated: October 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Genotype 2

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013