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NCT07255638
A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany
Conditions: Indolent Systemic Mastocytosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 80
Sponsor: Blueprint Medicines Corporation
Location: Charité Universitätmedizin Berlin, Institut für Allergieforschung Berlin
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07255638). StuddyBuddy aggregates publicly available trial information.