Phase 2 Study of Sildenafil for the Treatment of Lymphatic Malformations
Abstract
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
Conditions: Lymphatic Malformations, Lymphatic Diseases.
Primary outcome: Change in Lesion Volume of the Test Medication as Evaluated by MRI Examination..
Enrollment: 22 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 22 participants or records.
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