Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis
Status:
Completed
Trial end date:
2000-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety, tolerance, and immunologic effects of
interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is
to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of
Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10
will be given either alone or in combination with standard therapeutic agents, usually
consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to
receive IL-10 when there is evidence of active disease. IL-10 will be administered by
subcutaneous injection at a dose of 4 ยต (Micro)g/kg/day for 28 days.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)