Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT01639261
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01639261
Study Brief:
Protocol Section:
NCT01639261