Status:
RECRUITING
The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Communicating Hydrocephalus
Cerebral Intraventricular Hemorrhage
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This prospective, multicenter, open-label clinical trial is designed to evaluate the safety and efficacy of rapamycin in the treatment of communicating hydrocephalus secondary to intraventricular hemo...
Detailed Description
Communicating hydrocephalus secondary to intraventricular hemorrhage is a serious neurological disorder with the main clinical manifestations of ventricular dilatation, gait disturbance, cognitive dys...
Eligibility Criteria
Inclusion
- Patients with ventricular dilatation due to intraventricular hemorrhage who clinically present with any one or more of new gait disturbances, cognitive deficits, and urinary incontinence after remission of intraventricular hemorrhage symptoms, and whose brain imaging shows an Evans index (EI) of ≥0.3
- Age ≥ 18 years and ≤ 70 years
- Signed informed consent form
Exclusion
- Participation in another medical trial
- Have other disease that may affect the patient's symptoms (including gait disturbance, cognitive impairment, urinary incontinence)
- Allergy to the investigational drug
- Reduced liver function (increased INR or alanine transaminase concentrations in plasma elevated more than 1.5 times reference values)
- Reduced kidney function with GFR \< 50
- Concomitant treatment with strong CYP3A4/5 inducers or inhibitors, such as diltiazem, ketoconazole, or rifampicin.
- Active or uncontrolled chronic infection
- Women who are pregnant or breastfeeding
- Patients who are bedridden or require urinary catheters for extended periods of time.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06563817
Start Date
August 1 2024
End Date
July 1 2025
Last Update
August 21 2024
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070