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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753570
First Posted: December 20, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Toray Industries, Inc
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  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
Intervention Model: Parallel Assignment
Masking: None (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) ]

Secondary Outcome Measures:
  • Undetectable HCV RNA at 4 weeks after beginning of drug administration (RVR, rapid viral response) [ Time Frame: 4 weeks ]
  • 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) ]
  • Undetectable HCV RNA at 12 weeks after completion of drug administration [ Time Frame: 60 weeks(Genotype 1 groups), 36 weeks(Genotype 2 group) ]
  • Transition of serum HCV RNA levels [ Time Frame: From baseline to 24 weeks after completion of drug administration ]
  • Viral sequencing at the NS-3 protease region of HCV virus [ Time Frame: From baseline to 24 weeks after completion of drug administration ]

Enrollment: 74
Study Start Date: December 2012
Study Completion Date: October 2015
Primary Completion Date: October 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

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01753570     History of Changes
Other Study ID Numbers: G060-F1
First Submitted: December 13, 2012
First Posted: December 20, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Feron

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Interferon-beta
Interferon beta-1a
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic