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

Phase 2

• Conditions: Steroid-refractory Bronchiolitis Obliterans

• Registration Number: NCT01639261
• Lead Sponsor: University Hospital Regensburg

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 %

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-11
• Last Update Submitted: 2012-07-11
• Study First Posted: 2012-07-12
• Last Update Posted: 2012-07-12
• Primary Completion: 2013-12
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

• Age < 18 years
• Pregnant or nursing woman
• No appropriate contraception
• Participation in any other study within 4 weeks before or during the study
• Active acute GvHD of other organs than the lung > grade II or severe active chronic GvHD
• No appropriate antibiotic/ antimycotic therapy in documented infection
• Severe bone marrow suppression (ANC < 1000/ml) or graft failure
• Liver parameters (bilirubin, gammaGT, AP, ASAT and ALAT) higher than 3 x paramount normal range
• Kreatinin higher than 3 x paramount normal range
• Participation in another study within 4 weeks before or during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
therapy response	24 weeks	Enhancement of therapy response from 15 % to 50 %

Trial Locations

Locations (1)

University Hospital Regensburg; 🇩🇪 Regensburg, Germany