NCT06091332 Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
| NCT ID | NCT06091332 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Huashan Hospital |
| Condition | Cavernous Malformations |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2024-01-05 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 placebo. This pilot trial will inform the design of a future definitive clinical trial on sirolimus treatment for CCM.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-65 years, any gender; 2. Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation; 3. Diagnosed with solitary BSCM through T2, GRE/T2\*, or SWI MR imaging; 4. ICH within or around the BSCM confirmed by CT /MR; 5. Capable of signing an informed consent form with the accompaniment and understanding of a guardian. Exclusion Criteria: 1. Cancer history; 2. Pregnancy or lactation; 3. Sirolimus/starch allergy; 4. Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment; 5. 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); 6. History of previous immunosuppressive therapy; 7. History of prior surgical intervention for CCM ; 8. History of prior cranial radiation therapy ; 9. Familial CCM or people with multiple CCM; 10. Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections); 11. Uncontrolled diabetes mellitus; 12. Currently participating in another clinical trial; 13. Patient unwilling/unable to undergo MRI. 14. Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).
Contact & Investigator
Wei Zhu, Doctor
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT06091332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cavernous Malformations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06091332 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06091332 currently recruiting?
Yes, NCT06091332 is actively recruiting participants. Contact the research team at lizongze666@aliyun.com for enrollment information.
Where is the NCT06091332 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06091332 clinical trial?
NCT06091332 is sponsored by Huashan Hospital. The principal investigator is Wei Zhu, Doctor at Huashan Hospital. The trial plans to enroll 75 participants.