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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)

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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

December 13, 2012
December 20, 2012
July 20, 2017
October 26, 2018
October 26, 2018
December 2012
October 2015   (Final data collection date for primary outcome measure)
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) ]
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) ]
Complete list of historical versions of study NCT01753570 on ClinicalTrials.gov Archive Site
  • 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: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta) ]
  • 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) ]
  • 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 ]
  • 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.
  • 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 ]
Not Provided
Not Provided
 
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)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis C(CHC)
  • 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
  • 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, Genotype1
    Interventions:
    • Drug: MP-424
    • Drug: RBV(24 weeks)
    • Drug: IFN beta(24 weeks)
  • Experimental: RBV+IFN beta, Genotype1
    Interventions:
    • Drug: RBV(48 weeks)
    • Drug: IFN beta(48 weeks)
  • Experimental: MP-424+RBV+IFN beta, Genotype2
    Interventions:
    • Drug: MP-424
    • Drug: RBV(24 weeks)
    • Drug: IFN beta(24 weeks)
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-β 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
70
October 2015
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01753570
G060-F1
No
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Toray Industries, Inc
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP