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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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel 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 Treatment-Naïve Subjects With Genotype 1 Hepatitis C
Study Start Date : November 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRV/PEG/RBV 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

Active Comparator: PEG/RBV 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




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 ]


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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
  • 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

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): NCT00780416


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
Publications of Results:
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00780416    
Other Study ID Numbers: G060-A6
First Posted: October 27, 2008    Key Record Dates
Results First Posted: August 20, 2012
Last Update Posted: May 2, 2014
Last Verified: April 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Hepatitis C
Protease Inhibitor
Telaprevir
Peginterferon Alfa-2b
Ribavirin
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs