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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07255638). StuddyBuddy aggregates publicly available trial information.