Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

Hepatitis C Clinical Trial

Official title:

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780416
• Other study ID #: G060-A6
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2008
• Last updated: April 16, 2014
• Start date: November 2008
• Est. completion date: August 2010

Study information

• Verified date: April 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 (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Genotype 1, chronic hepatitis C

• Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• MP-424
750 mg every 8 hours for 12 weeks
• Ribavirin
600 - 1000 mg/day based on body weight for 24 weeks
• Peginterferon Alfa-2b
1.5 mcg/kg/week for 24 weeks
• Ribavirin
600 - 1000 mg/day based on body weight for 48 weeks
• Peginterferon Alfa-2b
1.5 mcg/kg/week for 48 weeks

Locations

Country	Name	City	State
Japan	Toranomon Hospital	Kawasaki City	Takatsu-ku

Sponsors (2)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation	Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol. 2012 Jan;56(1):78-84. doi: 10.1016/j.jhep.2011.07.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)		After 24 weeks of follow-up	No