Status:
RECRUITING
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
Lead Sponsor:
Huashan Hospital
Conditions:
Cavernous Malformations
Intracerebral Hemorrhage
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Age 18-65 years, any gender;
- Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation;
- Diagnosed with solitary BSCM through T2, GRE/T2\*, or SWI MR imaging;
- ICH within or around the BSCM confirmed by CT /MR;
- Capable of signing an informed consent form with the accompaniment and understanding of a guardian.
Exclusion
- Cancer history;
- Pregnancy or lactation;
- Sirolimus/starch allergy;
- Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;
- Abnormal liver and/or kidney function (transaminase levels greater than 50, creatinine greater than 110), abnormal white blood cell/platelet counts (white blood cell count below 3.5 or above 9.5 x 109/L or exceeding normal values, platelet count below 100 or above 300);
- History of previous immunosuppressive therapy;
- History of prior surgical intervention for CCM ;
- History of prior cranial radiation therapy ;
- Familial CCM or people with multiple CCM;
- Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections);
- Uncontrolled diabetes mellitus;
- Currently participating in another clinical trial;
- Patient unwilling/unable to undergo MRI.
- Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06091332
Start Date
January 5 2024
End Date
December 31 2026
Last Update
December 20 2024
Active Locations (2)
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1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
2
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040