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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: Improvement of quality of life in patients with BO and establishment of a new third line therapy

Detailed Summary:

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 %

Sponsor: University Hospital Regensburg

Current Primary Outcome: therapy response [ Time Frame: 24 weeks ]

Enhancement of therapy response from 15 % to 50 %


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital Regensburg

Dates:
Date Received: July 9, 2012
Date Started: July 2012
Date Completion: September 2014
Last Updated: July 11, 2012
Last Verified: July 2012