Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00780416
First received: October 24, 2008
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Hepatitis C
Drug: MP-424
Drug: Ribavirin
Drug: Peginterferon Alfa-2b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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 Treatment-Naïve Subjects With Genotype 1 Hepatitis C

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: November 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780416

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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00780416     History of Changes
Other Study ID Numbers: G060-A6
Study First Received: October 24, 2008
Results First Received: June 5, 2012
Last Updated: August 20, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Hepatitis C
Protease Inhibitor
Telaprevir
Peginterferon Alfa-2b
Ribavirin

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 April 17, 2014