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Completed

NCT Number: NCT00780910

Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after previous treatment.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C 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 3

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

  • Genotype 1, chronic hepatitis C
  • Relapsers (patient who relapsed after previous treatment)
  • Able and willing to follow contraception requirements

Exclusion criteria

  • Cirrhosis of the liver or hepatic failure
  • Hepatitis B surface antigen-positive or HIV antibodies-positive
  • History of, or concurrent hepatocellular carcinoma
  • History of, or concurrent depression, schizophrenia; or suicide attempt in the past
  • Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Treatment and study plan

MP-424

Drug

750 mg every 8 hours for 12 weeks

Other names: Telaprevir

Ribavirin

Drug

600 - 1000 mg/day based on body weight for 24 weeks

Peginterferon alfa-2b

Drug

1.5 mcg/kg/week for 24 weeks

Primary outcomes

  1. The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

    Time frame: After 24 weeks of follow-up

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Collaborators

  • Vertex Pharmaceuticals Incorporated

Registry information

Official study title

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 1 Hepatitis C Who Relapsed After Previous Treatment

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 28, 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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