Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy

This study is currently recruiting participants.

Verified by Mitsubishi Tanabe Pharma Corporation, October 2008

Sponsors and Collaborators:	Mitsubishi Tanabe Pharma Corporation Vertex Pharmaceuticals Incorporated
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00781274

Purpose

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with genotype 1 hepatitis C, who did not respond to previous treatment.

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

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b Interferons Telaprevir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 1 Hepatitis C Who Did Not Respond to Previous Treatment

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Undetectable HCV RNA at 24 weeks after completion of drug administration (SVR, sustained viral response) [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event, Adverse drug reaction [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MP-424: Experimental	Drug: MP-424 750 mg q8h for 12 weeks 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

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
Non-responders (patient who did not respond to previous treatment)
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: NCT00781274

Contacts

Contact: Clinical Trials Information Desk

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

Locations

Japan, Tokyo
Toranomon Hospital	Recruiting
Minato-ku, Tokyo, 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

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department III )
Study ID Numbers:	G060-A9
Study First Received:	October 24, 2008
Last Updated:	October 26, 2008
ClinicalTrials.gov Identifier:	NCT00781274
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009