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Completed

NCT Number: NCT00630058

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toranomon Hospital

Kawasaki, Takatsu-ku, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP-424(H), PEG-IFN-a-2b, RBV

Drug

MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Other names: Telaprevir

MP-424 (L), PEG-IFN-a-2b, RBV

Drug

MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Other names: Telaprevir

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Collaborators

  • Vertex Pharmaceuticals Incorporated

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2008
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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