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: April 16, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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: April 16, 2014
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 C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2b
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014