This trial is active, not recruiting.

Condition steroid-refractory bronchiolitis obliterans
Treatment interferon gamma 1b
Phase phase 2
Sponsor University Hospital Regensburg
Collaborator ClinAssess GmbH
Start date July 2012
End date December 2013
Trial size 10 participants
Trial identifier NCT01639261, 2010-022467-36, IFN_BOSZT_01


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

therapy response
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Allogeneic SCT - Age ≥ 18 years - BO, firmed by 2 out of 3 examinations: - Lung function/ BGA - CT scan in in- and expiration or - Histological diagnosis - Therapy refractory BO, i.e. no improvement during at least three therapies, among: - Azithromycin + inhaled steroids/ bronchodilators - Systemic steroids 1 mg/kg BW - One of the following therapies: MMF, mTOR inhibitors or ECP - Effective contraception (before, during and for 8 weeks after the treatment) - Blood count: no severe neutropenia, defined as ANC > 1000/ml, platelets > 50/nl and haemoglobin > 8 g/dl - Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) lower than 3 x paramount normal range - Kreatinin lower than 3 x paramount normal range - Informed consent 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

Additional Information

Official title Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
Principal investigator Ernst Holler, Professor MD
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 %
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by University Hospital Regensburg.