Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

Chronic Hepatitis C (CHC) Clinical Trial

Official title:

A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753557
• Other study ID #: G060-A12
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2012
• Last updated: August 17, 2015
• Start date: December 2012
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• 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 PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Genotype 1 CHC

• treatment-naïve or 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 (Human Immunodeficiency Virus) 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 (CHC)
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
• RBV
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
• PEG-IFN alfa-2a
PEG-IFN alfa-2a: 180mcg/week for 24 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 weeks after completion of drug administration (SVR, sustained viral response)		48 weeks	No
Secondary	Undetectable HCV RNA at 4 weeks after beginning of drug administration (RVR, rapid viral response)		4 weeks	No
Secondary	Undetectable HCV RNA at completion of drug administration (ETR, end-of-treatment response)		24 weeks	No
Secondary	Undetectable HCV RNA at 12 weeks after completion of drug administration		36 weeks	No
Secondary	Transition of serum HCV RNA levels		From baseline to 24 weeks after completion of drug administration	No
Secondary	Viral sequencing at the NS3 protease region of HCV virus		From baseline to 24 weeks after completion of drug administration	No