Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004695
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-05
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:
OBJECTIVES I Determine whether polyethylene-glycol-conjugated interleukin 2 PEG-IL-2 can reduce the number of infections in patients with common variable immunodeficiency
II Determine whether this therapy can improve lung functions in these patients with pulmonary impairment
II Determine whether this therapy can improve lung functions in these patients with pulmonary impairment
Detailed Description:
PROTOCOL OUTLINE This is a randomized open-label study Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 PEG-IL-2 or placebo
Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months Patients maintain a daily diary for 24 months
Patients are followed every 4 months for 2 years
Completion date provided represents the completion date of the grant per OOPD records
Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months Patients maintain a daily diary for 24 months
Patients are followed every 4 months for 2 years
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MTS-FDR001162 | None | None | None |
| MTS-93-726-ME | None | None | None |