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

This study is currently recruiting participants.

Verified by Mitsubishi Tanabe Pharma Corporation, August 2008

First Received: February 12, 2008 Last Updated: August 18, 2008 History of Changes

Sponsors and Collaborators:	Mitsubishi Tanabe Pharma Corporation Vertex Pharmaceuticals Incorporated
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00621296

Purpose

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	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of MP-424 in Patients With Genotype 1b Hepatitis C

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

HCV RNA kinetics and other viral characteristics [ Time Frame: 49 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Three tablets of MP-424 250mg tablet at a time, three times daily (Q8h), 24 weeks administration (dose in a day: 2250 mg)

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621296

Contacts

Contact: Clinical Trials Information Desk

cti-inq-ml@ml.mt-pharma.co.jp

Locations

Japan, Hokkaido
Sapporo-Kosei General Hospital	Recruiting
Sapporo-city, Hokkaido, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Vertex Pharmaceuticals Incorporated

Investigators

Study Director:	Kazuoki Kondo, MD	Mitsubishi Tanabe Pharma Corporation
Study Director:	Tadashi Yoshida, MD	Mitsubishi Tanabe Pharma Corporation

More Information

No publications provided

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department II )
Study ID Numbers:	G060-A7
Study First Received:	February 12, 2008
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00621296 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Chronic Hepatitis C
Protease Inhibitor

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic
Protease Inhibitors

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 06, 2009