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Recruiting NCT06360406

Real-World Treatment Study of Koselugo (Selumetinib)

Conditions: Neurofibromatosis 1, Neurofibroma, Plexiform

Sex: All
Ages: 3 Years – 99 Years
Healthy volunteers: No
Enrollment: 200
Sponsor: AstraZeneca

Location: Research Site Busan

Summary

As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea. This study will provide information on the Korean patient population that is treated with the study drug.

Eligibility Criteria

Inclusion Criteria: 1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: 1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

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

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06360406). StuddyBuddy aggregates publicly available trial information.