CompletedPhase 3

Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

Japan54 participantsStarted 2012-12

Plain-language summary

This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.

Who can participate

Age range20 Years – 65 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 CHC * treatment-naïve or 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 (Human Immunodeficiency Virus) 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

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: 48 weeks

Trial details

NCT IDNCT01753557

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2016-06-14

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