Last updated: February 5, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Stroke
Hemorrhage
Brain Injury
Treatment
CN-105
Clinical Study ID
NCT06255977
PR-CBT-2019040-2F
Ages 30-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Is male or female, age 30 to 80 years, inclusive;
- Has a confirmed diagnosis of spontaneous supratentorial ICH by CT;
- Able to receive first dose of study drug ≤ 12 hours after onset of ICH symptoms, suchas alteration in level of consciousness, severe headache, nausea, vomiting, seizure,and/or focal neurological deficits, or last-known well time;
- Has a GCS score ≥ 8 at enrollment;
- Has an NIHSS score ≥ 6
- Has Systolic BP (SBP) < 200 mmHg
- Has given written informed consent to participate in the study in accordance withrequired regulations; if a participant is not capable of providing informed consent,written consent must be obtained from the participant's legally authorizedrepresentative (LAR).
Exclusion
Exclusion Criteria:
- Is pregnant or lactating;
- Has a temperature greater than 38.5℃ at Screening;
- The amount of intracerebral hemorrhage< 5 mL( coniglobus formula)
- ICH known to result from trauma;
- Primary intraventricular hemorrhage;
- Radiographic evidence of underlying brain tumor;
- Patients with a history of malignant tumor (non-melanoma in situ skin cancer that hasachieved complete remission after treatment and has not relapsed in the past 5 yearsor other types eligible for inclusion in the opinion of the investigator);
- Known unstable mass or active radiographic evidence and symptoms of herniationseverely limiting the recovery potential of the patient in the opinion of theinvestigator;
- Known ruptured cerebral aneurysm, arteriovenous malformation, or vascular anomaly;hemorrhage from cerebral infarction, cerebral venous sinus embolization;
- Has a platelet count < 100×109/L,(INR) > 1.5 or irreversible coagulopathy either dueto medical condition or detected before screening;
- Is taking new oral anticoagulants (such as dabigatran etexilate, rivaroxaban,apixaban, etc.) or low molecular weight heparin at the time of ICH onset;
- In the opinion of the investigator is unstable and would benefit from supportive carerather than supportive care plus CN-105;
- In the opinion of the investigator has any contraindication to the planned studyassessments, including CT and MRI;
- Severe renal insufficiency: creatinine clearance <30 mL/ min (Cockcroft-Gaultformula), urea nitrogen and/or serum creatinine >1.5×ULN;
- Is scheduled for surgical intervention throughout the trial period dose, including butnot limited to hematoma evacuation (including minimally invasive and routine surgery),decompressive craniectomy, hematoma aspiration;
- Clinically significant history of cardiovascular disease, including; (1) congestiveheart failure (NYHA Class > 2); (2) unstable angina; (3) myocardial infarction in thepast 12 months; (4) any need for treatment or interventional supraventriculararrhythmia or ventricular arrhythmia;
- Has electrocardiogram (ECG) examination abnormalities deemed clinically significant bythe investigator: for example, QTc interval prolongation during screening (male > 450ms, female > 470 ms) (Note: QTc interval must be calculated according to Fridericia'scriteria);
- Subjects were disabled before disease onset (mRS ≥ 2)
- Patients with past intracranial hemorrhage such as cerebral hemorrhage, subarachnoidhemorrhage, or cerebral infarction/transient ischemic attack (TIA, but excludinglucunar infarction);
- Patients have other serious/severe acute or chronic mental illnesses, including recent (within the past 1 year) or current suicidal ideations or behaviors;
- May increase the risks associated with participating in research or study drugmanagement, or may interfere with the results of the study, or may interfere with theinvestigator's interpretation of laboratory abnormalities;
- Patients are employees of the research center or family members directly related tothe participants of this study, or subordinates who are not directly related to thetrial but are subordinates of the trial, or are employed by the sponsor directlyrelated to the trial;
- Is predisposed to allergy or known allergy to any ingredient in the study drug;
- Patients who have participated in other clinical trials or are participating inanother interventional clinical study within 3 months prior to enrollment;
- For other reasons, the investigator considered the subjects are inappropriate to beenrolled in the trial.
Study Design
Total Participants: 240
Treatment Group(s): 1
Primary Treatment: CN-105
Phase: 2
Study Start date:
August 24, 2022
Estimated Completion Date:
August 31, 2024
Study Description
Connect with a study center
Beijing Tiantan Hospital
Beijing,
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.