Chronic Hepatitis C (CHC) Clinical Trial
Official title:
A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Toranomon Hospital | Kawasaki City | Takatsu-ku |
Lead Sponsor | Collaborator |
---|---|
Mitsubishi Tanabe Pharma Corporation |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 weeks after completion of drug administration (SVR, sustained viral response) | 48 weeks | No | |
Secondary | Undetectable HCV RNA at 4 weeks after beginning of drug administration (RVR, rapid viral response) | 4 weeks | No | |
Secondary | Undetectable HCV RNA at completion of drug administration (ETR, end-of-treatment response) | 24 weeks | No | |
Secondary | Undetectable HCV RNA at 12 weeks after completion of drug administration | 36 weeks | No | |
Secondary | Transition of serum HCV RNA levels | From baseline to 24 weeks after completion of drug administration | No | |
Secondary | Viral sequencing at the NS3 protease region of HCV virus | From baseline to 24 weeks after completion of drug administration | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation
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A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)
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