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Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00781274
Recruitment Status : Completed
First Posted : October 28, 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

Study Description
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Brief Summary:
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: MP-424 Drug: Ribavirin Drug: Peginterferon Alfa-2b Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin (RBV) in Subjects With (Genotype 1) Hepatitis C Who Did Not Respond to Previous Treatment
Study Start Date : December 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MP-424 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Genotype 1, 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781274


Locations
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Japan
Toranomon Hospital
Kawasaki City, Takatsu-ku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Vertex Pharmaceuticals Incorporated
Investigators
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Principal Investigator: Fumitaka Suzuki, MD Department of Hepatology, Toranomon Hospital
More Information
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Publications of Results:

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00781274    
Other Study ID Numbers: G060-A9
First Posted: October 28, 2008    Key Record Dates
Results First Posted: August 20, 2012
Last Update Posted: May 2, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents