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Study Title: 5-arm, parallel-group study of the effects on viral kinetics, safety and pharmacokinetics of different dosing regimens of Debio 025 in combination with peginterferon alpha-2a and ribavirin in chronic HCV genotype 1 patients who non-responders to standard
Category: Gastroenterology
Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.
Principal Investigator: Chia Wang
Study Coordinator: Alice Stead
Phone: 206 341 1450 Ext.11450
Email: gasaes@vmmc.org
What is the 5-arm, parallel-group study of the effects on viral kinetics, safety and pharmacokinetics of different dosing regimens of Debio 025 in combination with peginterferon alpha-2a and ribavirin in chronic HCV genotype 1 patients who non-responders to standard study?
Who can participate?
What do I have to do as a study participant?
Study Summary:
Part II involves giving subjects peginterferon alpha-2a plus ribavirin for up to 68 weeks beyond the first month. At the end of Part I and Part II, the amount of HCV (viral load) in each subject will be analyzed (tested) to see if Debio 025 plus peginterferon alpha-2a and ribavirin is effective in treating long-term hepatitis C.
The purpose of this study is:
• To examine how Debio 025 plus peginterferon alpha-2a (180 ?g once weekly) and ribavirin (1000 or 1200 mg/day) affect the HCV viral load in subjects with long-term hepatitis C.
• To investigate how safe Debio 025 is.
• To determine how different dose levels of Debio 025 are tolerated.
• To observe how quickly Debio 025 is removed from the body after dosing (called pharmacokinetics-PK).
• To observe what the study drug does to the body after dosing (called pharmacodynamics PD) when Debio 025 has been given on its own and when it has been given in combination with peginterferon alpha-2a (180 ?g once weekly) and ribavirin (1000 or 1200 mg/day) to subjects with long-term hepatitis C.
Detailed Study Description:
Study Design: Observational
Phase of Study: Phase II
Study Type: Observational
Condition or Study Focus: Chronic HCV genotype 1 patients who are non-responders to standard peginterferon alpha and ribavirin treatment
Intervention Type: Debio 025 in combination with peginterferon alpha-2a and ribavirin
Intervention Name: Debio 025 in combination with peginterferon alpha-2a and ribavirin
Gender: Male and Female
Age group: Observational
Sponsor: Debiopharm S.A
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