NCT00381953

High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.

Detailed description

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a
DRUG	Interferon alfa-2a
DRUG	Ribavirin

Timeline

• Start date: 2003-02-01
• Primary completion: 2006-04-01
• Completion: 2006-07-01
• First posted: 2006-09-28
• Last updated: 2021-09-01

Locations

1 site across 1 country: Netherlands