ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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.
ClinicalTrials.gov Identifier: NCT01753570
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Toray Industries, Inc
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C(CHC) Drug: MP-424 Drug: RBV(24 weeks) Drug: IFN beta(24 weeks) Drug: RBV(48 weeks) Drug: IFN beta(48 weeks) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MP-424+RBV+IFN beta, Genotype1 Drug: MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks

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

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

Experimental: RBV+IFN beta, Genotype1 Drug: RBV(48 weeks)
RBV: 600 - 1000mg/day based on body weight for 48 weeks

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

Experimental: MP-424+RBV+IFN beta, Genotype2 Drug: MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks

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

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




Primary Outcome Measures :
  1. Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) [ Time Frame: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta) ]

Secondary Outcome Measures :
  1. Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) [ Time Frame: 4 weeks ]
  2. Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) [ Time Frame: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta) ]
  3. Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration [ Time Frame: 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta) ]
  4. Transition of Serum HCV RNA Levels [ Time Frame: Baseline,Day2,Day3,1Week,2Weeks,3Weeks,4Weeks,12Weeks,End of treatment,Follow-up 12weeks,Follow-up 24weeks ]
  5. Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV. [ Time Frame: From baseline to 24 weeks after completion of drug administration ]
    To examine the emergence of resistance-associated variants after MP-424 administration.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
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(Genotype 1 only) or patient who have ever had previous IFN based 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

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

Publications of Results:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01753570     History of Changes
Other Study ID Numbers: G060-F1
First Posted: December 20, 2012    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018
Last Verified: January 2018

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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs