NCT01639261

A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT

Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospital Regensburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 %

Conditions

• Steroid-refractory Bronchiolitis Obliterans

Interventions

Type	Name	Description
DRUG	Interferon gamma 1b	Initial dose: 50µg s.c. three times/week, without fever \>38,5 dose increase: 50µg/m² BSA three times/week

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-12-01
• Completion: 2014-09-01
• First posted: 2012-07-12
• Last updated: 2012-07-12

Locations

1 site across 1 country: Germany