NCT00624325

Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48 weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity and biologic potency due to sustained and higher levels of a fully potent interferon protein.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	interferon alfa-2b	12 MU daily continuously subcutaneous
DRUG	interferon alfa-2b	9 MU daily continuously subcutaneous
DRUG	interferon alfa-2b	6 MU daily continuously subcutaneous

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2008-02-27
• Last updated: 2011-03-11

Locations

1 site across 1 country: Netherlands