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Active Not RecruitingNCT05891847

Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia

Non-interventional Study of Patients With Plexiform Neurofibromas and Neurofibromatosis Type I Starting Selumetinib in Russia

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
AstraZeneca · Industry
Sex
All
Age
3 Years – 18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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

Conditions

Timeline

Start date
2023-03-21
Primary completion
2026-03-20
Completion
2026-03-20
First posted
2023-06-07
Last updated
2025-06-10

Locations

5 sites across 1 country: Russia

Source: ClinicalTrials.gov record NCT05891847. Inclusion in this directory is not an endorsement.