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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: MP-424(H), PEG-IFN-a-2b, RBV; Drug: MP-424 (L), PEG-IFN-a-2b, RBV

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Takatsu-ku
    • Kawasaki, Takatsu-ku, Japan
      • Toranomon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Telaprevir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum Observed Concentration in Plasma) of MP-424	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.	Data were collected at Day1 to Day85
Tmax (Time of Maximum Concentration in Plasma) of MP-424	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.	Data were collected at Day1 to Day85
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424	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.	Data were collected at Day1 to Day85
Ctrough (Minimum Observed Concentration in Plasma) of MP-424	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.	Data were collected at Day1 to Day85
T1/2(Time of Half-Life) of MP-424	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.	Data were collected at Day1 to Day85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels	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.	37 weeks

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Collaborators: Vertex Pharmaceuticals Incorporated
• Investigators: Principal Investigator: Fumitaka Suzuki, MD, Department of Hepatology, Toranomon Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 24, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimated): March 6, 2008

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Hepatitis C; Protease Inhibitor; Telaprevir
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis C; Hepatitis C, Chronic; Nucleic Acids, Nucleotides, and Nucleosides; Nucleosides; Ribonucleosides; Ribavirin; telaprevir
• Other Study ID Numbers: G060-A5