Evaluating a neuroprotective peptide for treating acute intracerebral hemorrhage
Official title: 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)
Run by Beijing Tiantan Hospital · NCT06255977 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06255977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 30 to 80 with a confirmed diagnosis of spontaneous supratentorial intracerebral hemorrhage.
✕Probably not a fit
Patients with intracerebral hemorrhage resulting from trauma or those with very small hemorrhages may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel, previous studies have indicated the potential of neuroprotective strategies in similar conditions.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Beijing Tiantan Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: yongjun Wang, Study Director
- Email: yongjunwang111@aliyun.com
- Phone: 13911172565
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Smartphone-based EEG to detect hidden awareness in ICU patients with brain injuries
Researchers will test a smartphone-enabled EEG to see if it can reveal Cognitive Motor Dissociation in ICU patients who can’t show commands at bedside.
-
Chinese multicenter group studies spontaneous intracerebral hemorrhage in adults
This study tests how a large group of adults with spontaneous intracerebral hemorrhage (and a healthy control group) progress over time to understand outcomes and determinants of recovery.
-
Rapid Evacuation and Access of Cerebral Hemorrhage Registry: observing minimally invasive surgery outcomes
This registry collection tests how minimally invasive brain-bleed procedures work in real patients with acute spontaneous intracerebral hemorrhage.
-
Single triple-combination blood pressure pill after intracerebral hemorrhage
This trial tests whether a single pill combining amlodipine, valsartan, and hydrochlorothiazide helps adults who recently had an intracerebral hemorrhage control their blood pressure.
-
Vitamin D treatment after intracerebral hemorrhage
This will try giving higher-dose vitamin D to adults within 96 hours of an intracerebral hemorrhage to see if it helps clear the bleed faster and is safe.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.