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A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C

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ClinicalTrials.gov Identifier: NCT00630058
Recruitment Status : Completed
First Posted : March 6, 2008
Results First Posted : January 18, 2013
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE February 24, 2008
First Posted Date  ICMJE March 6, 2008
Results First Submitted Date  ICMJE December 12, 2012
Results First Posted Date  ICMJE January 18, 2013
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
  • Cmax (Maximum Observed Concentration in Plasma) of MP-424 [ Time Frame: Data were collected at Day1 to Day85 ]
    Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
  • Tmax (Time of Maximum Concentration in Plasma) of MP-424 [ Time Frame: Data were collected at Day1 to Day85 ]
    Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
  • AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 [ Time Frame: Data were collected at Day1 to Day85 ]
    Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
  • Ctrough (Minimum Observed Concentration in Plasma) of MP-424 [ Time Frame: Data were collected at Day1 to Day85 ]
    Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
  • T1/2(Time of Half-Life) of MP-424 [ Time Frame: Data were collected at Day1 to Day85 ]
    Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
Pharmacokinetics of MP-424 [ Time Frame: 15 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels [ Time Frame: 37 weeks ]
HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
  • HCV RNA kinetics and other viral characteristics [ Time Frame: 37 weeks ]
  • Pharmacokinetics of PEG-IFN-a-2b [ Time Frame: 15 weeks ]
  • Pharmacokinetics of RBV [ Time Frame: 17 weeks ]
  • Safety [ Time Frame: 37 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Official Title  ICMJE A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C
Brief Summary The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: MP-424(H), PEG-IFN-a-2b, RBV
    MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
    Other Name: Telaprevir
  • Drug: MP-424 (L), PEG-IFN-a-2b, RBV
    MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
    Other Name: Telaprevir
Study Arms  ICMJE
  • Experimental: Group A (MP-424 High)
    Intervention: Drug: MP-424(H), PEG-IFN-a-2b, RBV
  • Experimental: Group B (MP-424 Low)
    Intervention: Drug: MP-424 (L), PEG-IFN-a-2b, RBV
Publications * Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29.

*   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: February 26, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed with genotype 1b chronic hepatitis C

Exclusion Criteria:

  • Patients diagnosed with decompensated cirrhosis
  • Patients diagnosed with positive HBs antigen in the test
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 NCT00630058
Other Study ID Numbers  ICMJE G060-A5
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 Vertex Pharmaceuticals Incorporated
Investigators  ICMJE
Principal Investigator: Fumitaka Suzuki, MD Department of Hepatology, Toranomon Hospital
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date April 2014

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