Status:
COMPLETED
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
Lead Sponsor:
Tanabe Pharma Corporation
Collaborating Sponsors:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatitis C
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.
Eligibility Criteria
Inclusion
- Genotype 1, chronic hepatitis C
- Non-responders (patient who did not respond to previous treatment)
- Able and willing to follow contraception requirements
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00781274
Start Date
December 1 2008
End Date
July 1 2010
Last Update
January 6 2026
Active Locations (1)
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1
Toranomon Hospital
Kawasaki, Takatsu-ku, Japan