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Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients

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: NCT01468584
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : November 2, 2014
Last Update Posted : November 2, 2014
Sponsor:
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 Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous treatment.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 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, in Subjects With Genotype 2 Hepatitis C, Who Did Not Respond to Previous Treatment
Study Start Date : November 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Undetectable HCV 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 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
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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): NCT01468584


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

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01468584    
Other Study ID Numbers: G060-A11
First Posted: November 9, 2011    Key Record Dates
Results First Posted: November 2, 2014
Last Update Posted: November 2, 2014
Last Verified: October 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Genotype 2
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
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
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents