Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT01639261
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2012-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
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:
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, i.e.:
* 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 O2/min 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 BO/BOOP at CT scan
* Reduction of steroids about at least 20 %
Objective improvement of lung function, i.e.:
* 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 O2/min 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 BO/BOOP at CT scan
* Reduction of steroids about at least 20 %
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-022467-36 | EUDRACT_NUMBER | None | View |