Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)

NCT01753570 | Completed Phase 3 Results

• 1 other identifier: G060-F1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.

Conditions

Chronic Hepatitis C(CHC)

Keywords

Feron

Outcome Measures

Primary Outcomes (1)

• Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

  72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)

Secondary Outcomes (5)

• 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)

  48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)

• Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration

  60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)

• Transition of Serum HCV RNA Levels

  Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks

• Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.

  From baseline to 24 weeks after completion of drug administration

Study Arms (3)

MP-424+RBV+IFN beta, Genotype1

EXPERIMENTAL

Drug: MP-424; Drug: RBV(24 weeks); Drug: IFN beta(24 weeks)

RBV+IFN beta, Genotype1

EXPERIMENTAL

Drug: RBV(48 weeks); Drug: IFN beta(48 weeks)

MP-424+RBV+IFN beta, Genotype2

EXPERIMENTAL

Drug: MP-424; Drug: RBV(24 weeks); Drug: IFN beta(24 weeks)

Interventions

RBV(24 weeks) DRUG

RBV: 600 - 1000mg/day based on body weight for 24 weeks

MP-424+RBV+IFN beta, Genotype1; MP-424+RBV+IFN beta, Genotype2

IFN beta(24 weeks) DRUG

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks

MP-424+RBV+IFN beta, Genotype1; MP-424+RBV+IFN beta, Genotype2

RBV(48 weeks) DRUG

RBV: 600 - 1000mg/day based on body weight for 48 weeks

RBV+IFN beta, Genotype1

IFN beta(48 weeks) DRUG

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks

RBV+IFN beta, Genotype1

MP-424 DRUG

MP-424: 750mg every 8 hours (q8h) for 12 weeks

MP-424+RBV+IFN beta, Genotype1; MP-424+RBV+IFN beta, Genotype2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
• Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based treatment
• Able and willing to follow contraception requirements

You may not qualify if:

• 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 serious depression, schizophrenia, or suicide attempt in the past
• Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead
• Toray Industries, Inc: collaborator

Study Sites (1)

Toranomon Hospital

Kawasaki, Takatsu-ku, 213-8587, Japan

Location

Related Publications (1)

• Kumada H, Mochida S, Nakamuta M, Suzuki F, Yagi T, Takasaki R, Okai M, Kamiya N, Okada Y, Hirota S, Orihashi M, Ochi M, Chayama K. Efficacy and safety of telaprevir with natural human interferon-beta and ribavirin in Japanese chronic hepatitis C patients with depression. Hepatol Res. 2018 Feb;48(2):184-192. doi: 10.1111/hepr.12914. Epub 2017 Jul 19.

  PMID: 28497489 RESULT

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; Interferon-beta

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Kazuoki Kondo, M.D.

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 20, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 6, 2026
• Results First Posted: October 26, 2018

Record last verified: 2025-12

Locations

JP (1)