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Recruiting NCT07255638

A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany

Conditions: Indolent Systemic Mastocytosis

Sponsor: Blueprint Medicines Corporation

trial.available_in: БГ
Overview
This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany. The study also seeks to address the existing data gap in the natural history and management of participants with ISM. The study is designed to follow each participant up to a maximum of 24 months.
Who can participate
Inclusion Criteria: * Participants is starting avapritinib treatment at the HCP's discretion as part of their routine care (for ISM with moderate to severe symptoms inadequately controlled with symptomatic treatment) and in accordance with approved SmPC. Exclusion Criteria: * Participant with a potential increased risk for intracranial hemorrhage including those with a history of vascular aneurysm, intracranial hemorrhage, cerebrovascular accident within the prior year, or severe thrombocytopenia. * Participant who has previously taken avapritinib as a commercial drug or as part of a clinical study.
Interventions
Avapritinib
DRUG
Locations 8
Germany (8)
Charité Universitätmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie
Berlin
Katholisches Klinikum Bochum
Bochum
MVZ Klinikum Deggendorf
Deggendorf
Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie
Dresden
University Medical Center Goettingen - Georg August University of Goettingen
Göttingen
Universitats-Hautklinik Tubingen, Studienzentrum lmmundermatologie
Tübingen
HNO-Gemeinschaftspraxis Wiesbaden, GEKA Gesellschaft für Experimentelle und Klinische Atemwegsforschung mbH, Zentrum für Rhinologie und Allergologie
Wiesbaden
Helios Universitätsklinikum Wuppertal
Wuppertal
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
09.12.2025
Completion date
01.12.2028
Registry ID
NCT07255638
Source
clinicaltrials.gov
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