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
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: MP-424(H), PEG-IFN-a-2b, RBV
Drug: MP-424 (L), PEG-IFN-a-2b, RBV
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A (MP-424 High) 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
Experimental: Group B (MP-424 Low) 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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630058

Locations
Japan
Toranomon Hospital
Kawasaki City, Takatsu-ku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Vertex Pharmaceuticals Incorporated
Investigators
Principal Investigator: Fumitaka Suzuki, MD Department of Hepatology, Toranomon Hospital
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00630058     History of Changes
Other Study ID Numbers: G060-A5
Study First Received: February 24, 2008
Results First Received: December 12, 2012
Last Updated: January 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Hepatitis C
Protease Inhibitor
Telaprevir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014