PASS of Paediatric Patients Initiating Selumetinib

Study identifier:D1346R00004

ClinicalTrials.gov identifier:NCT05388370

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

Post-Authorisation Safety Study of Paediatric Patients Initiating Selumetinib: A Multiple-Country Prospective Cohort Study

Medical condition

Neurofibromatosis Type 1

Phase

Phase 4

Healthy volunteers

No

Study drug

-

Sex

All

Estimated Enrollment

125

Study type

Observational

Age

3 Years - 17 Years

Date

Study Start Date: 23 May 2022
Estimated Primary Completion Date: 23 May 2028
Estimated Study Completion Date: 23 May 2028

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria