Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01639261
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2012-07-09
Brief Title:
A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT
Sponsor:
University Hospital Regensburg
Organization:
University Hospital Regensburg
Study Overview
Official Title:
Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
IFN_BOSZT_01
Brief Summary:
Improvement of quality of life in patients with BO and establishment of a new third line therapy
Detailed Description:
Primary Objectives
Objective improvement of lung function ie
Improvement of SO2 pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients 20 or
Reduction of oxygen need in oxygen dependent patients 1L O2min with constant parameters at blood gas analysis BGA or
Improvement of obstructive parameters 20 or
Improvement of lung function score LFS at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks
Secondary Objectives
Morphological improvement of BOBOOP at CT scan
Reduction of steroids about at least 20
Objective improvement of lung function ie
Improvement of SO2 pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients 20 or
Reduction of oxygen need in oxygen dependent patients 1L O2min with constant parameters at blood gas analysis BGA or
Improvement of obstructive parameters 20 or
Improvement of lung function score LFS at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks
Secondary Objectives
Morphological improvement of BOBOOP at CT scan
Reduction of steroids about at least 20
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 |
|---|---|---|---|
| 2010-022467-36 | EUDRACT_NUMBER | None | None |