Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001761
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I Trial of Recombinant Human Interleukin-10 SCH 52000 in Patients With Wegeners Granulomatosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Trial of Recombinant Human Interleukin-10 SCH 52000 in Patients With Wegeners Granulomatosis
Status:
COMPLETED
Status Verified Date:
1999-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety tolerance and immunologic effects of interleukin-10 IL-10 in patients with Wegeners granulomatosis A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegeners 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 andor 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 µ Microgkgday for 28 days
Detailed Description:
The purpose of the study is to assess the safety tolerance and immunologic effects of interleukin-10 IL-10 in patients with Wegeners granulomatosis A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegeners 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 andor 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 µ Microgkgday for 28 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-I-0059 | None | None | None |