Actively Recruiting
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
Led by Huashan Hospital · Updated on 2024-12-20
75
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years, any gender
- First symptomatic brainstem cavernous malformation intracerebral hemorrhage within six months before randomization
- Diagnosed with solitary brainstem cavernous malformation by MRI (T2, GRE/T2*, or SWI sequences)
- Intracerebral hemorrhage within or around the brainstem cavernous malformation confirmed by CT or MRI
- Able to sign informed consent with guardian assistance and understanding
You will not qualify if you...
- History of cancer
- Pregnancy or breastfeeding
- Allergy to sirolimus or starch
- Modified Rankin Scale score of 5, respiratory failure, or severe bleeding requiring life support
- Abnormal liver or kidney function (transaminase >50, creatinine >110)
- Abnormal white blood cell count (<3.5 or >9.5 x 10^9/L) or platelet count (<100 or >300)
- History of immunosuppressive therapy
- Previous surgical treatment for cavernous malformations
- Prior cranial radiation therapy
- Familial or multiple cavernous malformations
- Current acute severe infections
- Uncontrolled diabetes mellitus
- Participation in another clinical trial
- Unable or unwilling to undergo MRI
- Use of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Active, Not Recruiting
2
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
Z
Zongze Li, Doctor
CONTACT
W
Wei Zhu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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