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

This study has been completed.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00630058
First received: February 24, 2008
Last updated: January 17, 2013
Last verified: January 2013

February 24, 2008
January 17, 2013
April 2008
March 2009   (final data collection date for primary outcome measure)
  • Cmax (Maximum Observed Concentration in Plasma) of MP-424 [ Time Frame: Data were collected at Day1 to Day85 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.

Pharmacokinetics of MP-424 [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00630058 on ClinicalTrials.gov Archive Site
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
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.
  • HCV RNA kinetics and other viral characteristics [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics of PEG-IFN-a-2b [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics of RBV [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 37 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Hepatitis C
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00630058
G060-A5
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Vertex Pharmaceuticals Incorporated
Principal Investigator: Fumitaka Suzuki, MD Department of Hepatology, Toranomon Hospital
Mitsubishi Tanabe Pharma Corporation
January 2013

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