steroid-refractory bronchiolitis obliterans MedDRA version: 13.1 Level: PT Classification code 10029888 Term: Obliterative bronchiolitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Imukin
Product Name: Imukin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon gamma-1b
CAS Number: 98059-61-1
Current Sponsor code: Imukin
Other descriptive name:
Sponsors
Freistaat Bayern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Allogeneic SCT • Age = 18 years • BO, firmed by 2 out of 3 examinations: o Lung function/ BGA o CT scan in in- and exspiration or o Histological diagnosis • Therapy refractory BO, i.e. no improvement during at least three therapies, among: o Azithromycin + inhaled steroids/ bronchodilatators o Systemic steroids 1 mg/kg BW o 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 or cytopenia, defined as ANC > 1000/ml, platelets > 50/nl and haemoglobin > 8 g/dl • Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) below 3x normal range • Creatinin below 3x normal range • Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Age 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) above 3x normal range • Creatinin above 3x normal range • Participation in another study within 4 weeks before or during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective improvement of lung function, i.e.: • Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in ventilated patients = 20 % or • Reduction of oxygen need in oxygen dependent patients = 1L O2/min without deterioration of parameters in 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 Objective: • Morphological improvement of BO/BOOP at CT scan • Reduction of steroids (dose/day) about at least 20 % ;Primary end point(s): lung function testing, blood gas analysis;Timepoint(s) of evaluation of this end point: for all 4 weeks until week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CT, reduction of steroids about at least 20 %;Timepoint(s) of evaluation of this end point: CT: after 12 and 24 weeks reduction of steroid: for all 4 weeks until week 24 | — |
Countries
Germany
Contacts
Public ContactHeike Kassubek
Klinikum der Universität Regensburg
Outcome results
None listed