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 ongoing, but not recruiting participants.
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: July 10, 2014
Last verified: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753570

Locations
Japan
Toranomon Hospital
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: July 10, 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 July 28, 2014