High-Dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
Drug: Peginterferon alfa-2a
Drug: Interferon alfa-2a
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparative Study of High-Dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV|
- To compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCV RNA suppression of 360 mug peginterferon alfa-2a QW, 9 MU interferon alfa-2a daily or 4,5 interferon alfa-2a daily in combination with 180 mug peginterferon alfa-2a QW in the
- To compare the virological breakthrough/relapse rate after dose adjustments (at 4,24,72) weeks.
- To compare the sustained virological response rate at 24 weeks after end of treatment.
|Study Start Date:||February 2003|
|Study Completion Date:||July 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381953
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3015 CE|
|Principal Investigator:||Rob J. de Knegt, MD, PhD||Erasmus Medical Center|