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Trial record 2 of 329 for:    IFNA2 AND RBV AND Hepatitis

Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

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: NCT01753557
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE December 13, 2012
First Posted Date  ICMJE December 20, 2012
Results First Submitted Date  ICMJE June 14, 2016
Results First Posted Date  ICMJE October 3, 2016
Last Update Posted Date October 3, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01753557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • 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 ]
  • Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration [ Time Frame: 36 weeks ]
  • Transition of Serum HCV RNA Levels [ Time Frame: baseline,Day2,Day3,1Weeks,2Weeks,3Weeks,4Weeks,End of treatment,Follow-up 12weeks,Follow-up 24weeks ]
  • Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus(Result of Resistance-associated Variants Analysis) [ Time Frame: From baseline to 24 weeks after completion of drug administration ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
  • 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 ]
  • Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration [ Time Frame: 36 weeks ]
  • Transition of Serum HCV RNA Levels [ Time Frame: From baseline to 24 weeks after completion of drug administration ]
  • Viral sequencing at the NS3 protease region of HCV virus [ Time Frame: From baseline to 24 weeks after completion of drug administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
Official Title  ICMJE A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment
Brief Summary This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C (CHC)
Intervention  ICMJE
  • 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 24 weeks
  • Drug: PEG-IFN alfa-2a
    PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Study Arms  ICMJE
  • Experimental: Treatment-Naive
    Interventions:
    • Drug: MP-424
    • Drug: RBV
    • Drug: PEG-IFN alfa-2a
  • Experimental: Treatment-Relapsed
    Interventions:
    • Drug: MP-424
    • Drug: RBV
    • Drug: PEG-IFN alfa-2a
Publications * Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon α-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
54
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2012)
50
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Genotype 1 CHC
  • treatment-naïve or relapsers (patient who relapsed after 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 (Human Immunodeficiency Virus) antibodies-positive
  • History of, or concurrent hepatocellular carcinoma
  • History of, or concurrent depression, schizophrenia, or suicide attempt in the past
  • Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01753557
Other Study ID Numbers  ICMJE G060-A12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date August 2016

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