CompletedPhase 3

Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)

Japan74 participantsStarted 2012-12

Plain-language summary

This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.

Who can participate

Age range20 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Genotype 1 or 2, chronic hepatitis C, with depression(including the past) * Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based 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 serious depression, schizophrenia, or suicide attempt in the past * Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

What they're measuring

Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

Timeframe: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)

Trial details

NCT IDNCT01753570

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10

Results submitted2017-07-20

View on ClinicalTrials.gov More Chronic Hepatitis C(CHC) trials