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

Chronic Hepatitis C Clinical Trial

Official title:

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466192
• Other study ID #: G060-A10
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2011
• Last updated: October 29, 2014
• Start date: May 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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 relapsed after previous treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Genotype 2, chronic hepatitis C

• Relapsers (patient who relapsed after 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

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
Japan	Toranomon Hospital	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kumada H, Sato K, Takehara T, Nakamuta M, Ishigami M, Chayama K, Toyota J, Suzuki F, Nakayasu Y, Ochi M, Yamada I, Okanoue T. Efficacy of telaprevir-based therapy for difficult-to-treat patients with genotype 2 chronic hepatitis C in Japan. Hepatol Res. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)		After 24 weeks of follow-up	No