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RECRUITING
NCT06091332
PHASE2

Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

The aim of this pilot phase trial is to assess the safety and tolerability, and estimate the efficacy of sirolimus in reducing the incidence of ICH during high-risk periods for rebleeding, compared to placebo. This pilot trial will inform the design of a future definitive clinical trial on sirolimus treatment for CCM.

Official title: Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: a Randomized, Placebo-controlled Pilot Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-01-05

Completion Date

2026-12-31

Last Updated

2024-12-20

Healthy Volunteers

No

Interventions

DRUG

Sirolimus

Sirolimus is an mTORC1 inhibitor that has received approval from the U.S. Food and Drug Administration (FDA) and has recently been successfully used to treat lymphatic malformations and venous/lymphatic malformations associated with the same PIK3CA GOF mutations.

DRUG

Starch flake

The placebo is composed of starch material and is formulated at 0.5 grams per tablet.

Locations (2)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China