Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT01468584

First received: November 2, 2011

Last updated: October 16, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2011

Last Updated Date

October 16, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01468584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients

Official Title ^ICMJE

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Subjects With Genotype 2 Hepatitis C, Who Did Not Respond to Previous Treatment

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

Drug: MP-424 (generic name:Telaprevir)
750mg q8h for 12 weeks
Drug: Ribavirin
400 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon alfa-2b
1.5mcg/kg/week for 24 weeks

Study Arm (s)

Experimental: MP-424

Interventions:

Drug: MP-424 (generic name:Telaprevir)
Drug: Ribavirin
Drug: Peginterferon alfa-2b

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Genotype 2, 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

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01468584

Other Study ID Numbers ^ICMJE

G060-A11

Has Data Monitoring Committee

Responsible Party

Mitsubishi Tanabe Pharma Corporation

Study Sponsor ^ICMJE

Mitsubishi Tanabe Pharma Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kazuoki Kondo, MD

Mitsubishi Tanabe Pharma Corporation

Information Provided By

Mitsubishi Tanabe Pharma Corporation

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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