Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C

This study has been completed.
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation Identifier:
First received: February 12, 2008
Last updated: April 16, 2014
Last verified: April 2014
The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.

Condition Intervention Phase
Hepatitis C
Drug: MP-424 (Telaprevir)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of MP-424 in Patients With (Genotype 1b) Hepatitis C

Resource links provided by NLM:

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration [ Time Frame: 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug. ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-424 Drug: MP-424 (Telaprevir)
Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
Other Name: Telaprevir


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed with genotype 1b chronic hepatitis C
  • Patients naive to the concomitant medications with interferon

Exclusion Criteria:

  • Patients diagnosed with decompensated cirrhosis
  • Patients diagnosed with positive HBs antigen in the test
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Please refer to this study by its identifier: NCT00621296

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

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT00621296     History of Changes
Other Study ID Numbers: G060-A7 
Study First Received: February 12, 2008
Results First Received: September 19, 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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on May 22, 2016