Study identifier:D1340R00002
ClinicalTrials.gov identifier:NCT05891847
EudraCT identifier:N/A
CTIS identifier:N/A
Non-interventional study of patients with plexiform neurofibromas and neurofibromatosis type I starting selumetinib in Russia
neurofibroma
N/A
No
-
All
150
Observational
3 Years - 18 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
-
The purpose of this study is to evaluate the effectiveness, safety of selumetinib and patient’s parameters of symptomatic inoperable PN NF1 in real clinical practice in Russia
This study will be non-interventional retrospective and prospective study. Assessment of parameters will be carried out as if a patient is treated in real-life clinical setting. The patients should be enrolled into this project after evaluation of eligibility criteria by an investigator 10 clinical sites. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Study population will consist of pediatric patients aged 3 years and older with NF1 and symptomatic inoperable PN who were prescribed with selumetinib
Location
Location
Moscow, Moskva, Russian Federation, 123112
Location
Ekaterinburg, Russian Federation
Location
Saint-Petersburg, Russian Federation
Location
Novosibirsk, Russian Federation
Location
Moscow, Russian Federation
Arms | Assigned Interventions |
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