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

Phase 3

Completed

• Conditions: Chronic Hepatitis C (CHC)
• Interventions: Drug: MP-424; Drug: RBV; Drug: PEG-IFN alfa-2a

• Registration Number: NCT01753557
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-06-14
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Results First Posted: 2016-10-03
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment-Naive	MP-424	-
Treatment-Naive	RBV	-
Treatment-Naive	PEG-IFN alfa-2a	-
Treatment-Relapsed	MP-424	-
Treatment-Relapsed	RBV	-
Treatment-Relapsed	PEG-IFN alfa-2a	-

Primary Outcome Measures

Name	Time	Method
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)	48 weeks

Secondary Outcome Measures

Name	Time	Method
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)	From baseline to 24 weeks after completion of drug administration
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)	4 weeks
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)	24 weeks
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration	36 weeks
Transition of Serum HCV RNA Levels	baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks

Trial Locations

Locations (1)

Toranomon Hospital; 🇯🇵 Kawasaki City, Takatsu-ku, Japan