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: April 16, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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: April 16, 2014
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
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014