Sildenafil for the Treatment of Lymphatic Malformations
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
A Phase 2 study to evaluate safety and efficacy of sildenafil taken orally to improve or
resolve lymphatic malformations in children. Subjects may receive either placebo or treatment
in an oral dosage with an open label extension for subjects who received placebo. The study
treatment assignment will be randomized in a double blind fashion. MRI examination will
evaluate change in lesion volume due to treatment. Other safety and efficacy measures will be
taken through the 32-week study duration.
Funding Source - FDA OOPD
Phase:
Phase 2
Details
Lead Sponsor:
Stanford University
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago