Evaluating a neuroprotective peptide for treating acute intracerebral hemorrhage

A Multicenter, Randomized, Blind, Placebo-controlled, Dose-finding Phase II Trial Evaluating the Safety and Efficacy of the Neuroprotective Peptide CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage (CN-CATCH)

This study is testing a new treatment called CN-105 to see if it can help improve recovery for people aged 30 to 80 who have had a type of brain bleed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06255977 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and efficacy of a neuroprotective peptide called CN-105 in patients with acute supratentorial intracerebral hemorrhage. Participants aged 30 to 80 years will receive intravenous infusions of CN-105 every 6 hours for up to 72 hours, with a total of 240 patients expected to be enrolled. The study aims to determine how well CN-105 can improve outcomes after intracerebral hemorrhage, a condition currently lacking effective treatments. Blood samples will be collected to analyze protein markers at specified intervals during the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 80 with a confirmed diagnosis of spontaneous supratentorial intracerebral hemorrhage.

Not a fit: Patients with intracerebral hemorrhage resulting from trauma or those with very small hemorrhages may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute intracerebral hemorrhage.

How similar studies have performed: While this approach is novel, previous studies have indicated the potential of neuroprotective strategies in similar conditions.

Eligibility criteria

Inclusion Criteria:

1. Is male or female, age 30 to 80 years, inclusive;
2. Has a confirmed diagnosis of spontaneous supratentorial ICH by CT;
3. Able to receive first dose of study drug ≤ 12 hours after onset of ICH symptoms, such as alteration in level of consciousness, severe headache, nausea, vomiting, seizure, and/or focal neurological deficits, or last-known well time;
4. Has a GCS score ≥ 8 at enrollment;
5. Has an NIHSS score ≥ 6
6. Has Systolic BP (SBP) \< 200 mmHg
7. Has given written informed consent to participate in the study in accordance with required regulations; if a participant is not capable of providing informed consent, written consent must be obtained from the participant's legally authorized representative (LAR).

Exclusion Criteria:

1. Is pregnant or lactating;
2. Has a temperature greater than 38.5℃ at Screening;
3. The amount of intracerebral hemorrhage\< 5 mL（ coniglobus formula）
4. ICH known to result from trauma;
5. Primary intraventricular hemorrhage；
6. Radiographic evidence of underlying brain tumor;
7. Patients with a history of malignant tumor (non-melanoma in situ skin cancer that has achieved complete remission after treatment and has not relapsed in the past 5 years or other types eligible for inclusion in the opinion of the investigator);
8. Known unstable mass or active radiographic evidence and symptoms of herniation severely limiting the recovery potential of the patient in the opinion of the investigator;
9. Known ruptured cerebral aneurysm, arteriovenous malformation, or vascular anomaly; hemorrhage from cerebral infarction, cerebral venous sinus embolization;
10. Has a platelet count \< 100×109/L，(INR) \> 1.5 or irreversible coagulopathy either due to medical condition or detected before screening;
11. Is taking new oral anticoagulants (such as dabigatran etexilate, rivaroxaban, apixaban, etc.) or low molecular weight heparin at the time of ICH onset;
12. In the opinion of the investigator is unstable and would benefit from supportive care rather than supportive care plus CN-105;
13. In the opinion of the investigator has any contraindication to the planned study assessments, including CT and MRI;
14. Severe renal insufficiency: creatinine clearance \<30 mL/ min (Cockcroft-Gault formula), urea nitrogen and/or serum creatinine \>1.5×ULN;
15. Is scheduled for surgical intervention throughout the trial period dose, including but not limited to hematoma evacuation (including minimally invasive and routine surgery), decompressive craniectomy, hematoma aspiration；
16. Clinically significant history of cardiovascular disease, including; (1) congestive heart failure (NYHA Class \> 2); (2) unstable angina; (3) myocardial infarction in the past 12 months; (4) any need for treatment or interventional supraventricular arrhythmia or ventricular arrhythmia;
17. Has electrocardiogram (ECG) examination abnormalities deemed clinically significant by the investigator: for example, QTc interval prolongation during screening (male \> 450 ms, female \> 470 ms) (Note: QTc interval must be calculated according to Fridericia's criteria);
18. Subjects were disabled before disease onset (mRS ≥ 2)
19. Patients with past intracranial hemorrhage such as cerebral hemorrhage, subarachnoid hemorrhage, or cerebral infarction/transient ischemic attack (TIA, but excluding lucunar infarction);
20. Patients have other serious/severe acute or chronic mental illnesses, including recent (within the past 1 year) or current suicidal ideations or behaviors;
21. May increase the risks associated with participating in research or study drug management, or may interfere with the results of the study, or may interfere with the investigator's interpretation of laboratory abnormalities;
22. Patients are employees of the research center or family members directly related to the participants of this study, or subordinates who are not directly related to the trial but are subordinates of the trial, or are employed by the sponsor directly related to the trial;
23. Is predisposed to allergy or known allergy to any ingredient in the study drug;
24. Patients who have participated in other clinical trials or are participating in another interventional clinical study within 3 months prior to enrollment;
25. For other reasons, the investigator considered the subjects are inappropriate to be enrolled in the trial.

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: yongjun Wang, Study Director

Conditions Intracerebral Hemorrhage