Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029328
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-10
Brief Title:
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Soluble Tumor Necrosis Factor Receptor Enbrel Etanercept for the Treatment of Acute Pulmonary Dysfunction Idiopathic Pneumonia Syndrome Following Allogeneic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of etanercept and define the toxicity when administered to patients with acute non-infectious lung injury idiopathic pneumonia syndrome IPS and with subacute pulmonary dysfunction after allogeneic stem cell transplantation
Detailed Description:
Over the last 2 decades allogeneic bone marrow transplantation BMT has emerged as an important treatment option for a number of malignant and non-malignant disorders Unfortunately pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor TNF Etanercept is an experimental drug that attempts to block TNF lung damage Patients will undergo blood tests x-rays and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection If no infection is evident after 24 hours the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection There will be weekly blood tests and bronchoscopy after the last drug dose
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 |
|---|---|---|---|
| FD-R-002020-01 | None | None | None |
| UMCC-0078 | None | None | None |