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)

This study is currently recruiting participants.
Verified January 2014 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Collaborator:
Toray Industries, Inc
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01753570
First received: December 13, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C(CHC)
Drug: MP-424
Drug: RBV
Drug: IFN beta
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Study of MP-424 in Combination With IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 weeks after completion of drug administration (SVR, sustained viral response) [ Time Frame: 72 weeks(Genotype 1 groups), 48 weeks(Genotype 2 group) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Undetectable HCV RNA at 4 weeks after beginning of drug administration (RVR, rapid viral response) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Undetectable HCV RNA at completion of drug administration (ETR, end-of-treatment response) [ Time Frame: 24 weeks(Genotype 1 groups), 24 weeks(Genotype 2 group) ] [ Designated as safety issue: No ]
  • Undetectable HCV RNA at 12 weeks after completion of drug administration [ Time Frame: 60 weeks(Genotype 1 groups), 36 weeks(Genotype 2 group) ] [ Designated as safety issue: No ]
  • Transition of serum HCV RNA levels [ Time Frame: From baseline to 24 weeks after completion of drug administration ] [ Designated as safety issue: No ]
  • Viral sequencing at the NS-3 protease region of HCV virus [ Time Frame: From baseline to 24 weeks after completion of drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-424(+RBV+IFN), Genotype1 Drug: MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
Drug: RBV
RBV: 600 - 1000 mg/day based on body weight for 48 weeks
Drug: IFN beta
IFN: 600 MIU/day, 6 days/week for initial 4 weeks following to 3 days/week
Experimental: RBV+IFN, Genotype1 Drug: RBV
RBV: 600 - 1000 mg/day based on body weight for 48 weeks
Drug: IFN beta
IFN: 600 MIU/day, 6 days/week for initial 4 weeks following to 3 days/week
Experimental: MP-424(+RBV+IFN), Genotype2 Drug: MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
Drug: RBV
RBV: 600 - 1000 mg/day based on body weight for 48 weeks
Drug: IFN beta
IFN: 600 MIU/day, 6 days/week for initial 4 weeks following to 3 days/week

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
  • treatment-naïve or patient who have ever had 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 serious depression, schizophrenia,; or suicide attempt in the past
  • Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753570

Contacts
Contact: Clinical Trials Information Desk cti-inq-ml@ml.mt-pharma.co.jp

Locations
Japan
Toranomon Hospital Recruiting
Kawasaki City, Takatsu-ku, Japan, 213-8587
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Toray Industries, Inc
Investigators
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01753570     History of Changes
Other Study ID Numbers: G060-F1
Study First Received: December 13, 2012
Last Updated: January 6, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Feron

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-beta
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014