Intracerebral HemorrhagePhase 2NCT06255977
A Study Evaluating the Safety and Efficacy of Neuroprotective Peptide CN-105 Peptide in Patients With Acute Supratentorial Intracerebral Hemorrhage
A Phase 2 study testing CN-105 in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Intracerebral hemorrhage (ICH) is a devastating form of cerebrovascular disease for which there are no approved therapeutics that improve outcomes. Apolipoprotein E (apoE) has emerged as a promising therapeutic target given its isoform-specific neuroprotective properties and ability to modulate neuroinflammatory… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- CN-105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2022to Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, such as 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 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).
Who cannot join
- 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;
Show all 25Show fewer
- 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);
- 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;
- 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 due to 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 care rather than supportive care plus CN-105;
- In the opinion of the investigator has any contraindication to the planned study assessments, including CT and MRI;
- Severe renal insufficiency: creatinine clearance <30 mL/ min (Cockcroft-Gault formula), urea nitrogen and/or serum creatinine >1.5×ULN;
- 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；
- 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;
- 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);
- Subjects were disabled before disease onset (mRS ≥ 2)
- Patients with past intracranial hemorrhage such as cerebral hemorrhage, subarachnoid hemorrhage, or cerebral infarction/transient ischemic attack (TIA, but excluding lucunar 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 drug management, or may interfere with the results of the study, or may interfere with the investigator's interpretation of laboratory abnormalities;
- 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;
- 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 in another interventional clinical study within 3 months prior to enrollment;
- For other reasons, the investigator considered the subjects are inappropriate to be enrolled in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing
yongjun Wang, 13911172565, yongjunwang111@aliyun.com
About this study
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)
Intracerebral hemorrhage (ICH) is a devastating form of cerebrovascular disease for which there are no approved therapeutics that improve outcomes. Apolipoprotein E (apoE) has emerged as a promising therapeutic target given its isoform-specific neuroprotective properties and ability to modulate neuroinflammatory responses. We developed a 5-amino acid peptide, CN-105, that mimics the polar face of the apoE helical domain involved in receptor interactions, readily crosses the blood-brain barrier, and improves outcomes in well-established preclinical ICH models. In the current study, aim to assess the safety and the efficacy of CN-105 after administration for three consecutive days in participants with acute supratentorial ICH at three different dosages.
Read the detailed description
Inclusion Patients with spontaneous acute supratentorial intracerebral hemorrhage confirmed by CT，age 30 to 80 years，Intravenous infusion with CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours。
Blood samples for protein markers will be collected and detected at screening, 48 h(D3), and 120 h(D6) after the first dose:
The sample size is 240.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- CN-105
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CN-105Drug
Also called CN-105peptide
Injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control: placebo | Placebo comparator | Intravenous infusion with placebo（same volume of saline） every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of placebo（same volume of saline） will be administered as a slow IV bolus over 30 minutes. Receives: Drug: CN-105 |
| Experimental: CN-105 peptide for injection 0.1 mg/kg | Experimental | Intravenous infusion with 0.1 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes. Receives: Drug: CN-105 |
| Experimental:CN-105 peptide for injection 0.3 mg/kg | Experimental | Intravenous infusion with 0.3 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes. Receives: Drug: CN-105 |
| Experimental: CN-105 peptide for injection 1.0 mg/kg | Experimental | Intravenous infusion with 1.0 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes. Receives: Drug: CN-105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
Number and severity of AEs throughout the duration of the study;
Measured: 90±7 days
SAEs
Number and severity of SAEs throughout the duration of the study;
Measured: 90±7 days
Treatment-related mortality;
Treatment-related mortality throughout the duration of the study;
Measured: 90±7 days
Deaths
Rate of mortality at 14-day, 30-day, and 90-day ;
Measured: Day14, Day30,Day90
Incidence of cerebritis, meningitis, ventriculitis;
Incidence of cerebritis, meningitis, ventriculitis throughout the duration of the study;
Measured: 90±7 days
Incidence of systemic infection associated with intracerebral hemorrhage
Incidence of systemic infection associated with intracerebral hemorrhage throughout the duration of the study;
Measured: 90±7 days
The incidence of hematoma extension
The incidence of hematoma extension in 24-48 h after the first dose of study drug administration relative to baseline；
Measured: 24-48 hour （Day2~Day3）
Secondary outcomes (8)
Modified Rankin Scale(mRS)
The proportion of patients alive and independent (mRS 0-2) on D90;
Measured: Day90
National Institutes of Health Stroke Scale (NIHSS)
During dosing neurological deterioration, defined as an increase of National Institutes of National Institutes of Health Stroke Scale (NIHSS) > 2 from baseline( unrelated to sedation)；
Measured: 90±7 days
contrast head CT to evaluate progression of perihematomal edema;
At screening, 24h (D2), 48h (D3) and 120h (D6) after the first dose and D14, non-contrast head CT to evaluate progression of perihematomal edema;
Measured: screening, 24hour (Day2), 48hour (Day3) and 120hour (Day6),Day14
Modified Rankin Scale(mRS)
At D30 The proportion of patients alive and independent (mRS 0-2) and the distribution of mRS scores（shift analysis）at D30, D90;
Measured: Day30
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS) assessment at D3, D14;
Measured: Day3, Day14
Barthel Index assessment
Barthel Index assessment at D14, D30, D90;
Measured: Day14, Day30, Day90
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) Score at D2, D30;
Measured: Day2, Day30
MRI to evaluate the severity of neuronal injury and determine the progression of perihematomal edema respectively ；
At screening, 48h (D3), 120h (D6) after the first dose of study drug, MRI to evaluate the severity of neuronal injury and determine the progression of perihematomal edema respectively ；
Measured: screening, 48hour (Day3), 120hour (Day6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start24 Aug 2022
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SDM Bio Service Inc.
- Responsible party
- Sponsor
- Investigators
- shuya Li, Study Director, Study director, IRB of Beijing Tiantan Hospital,Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255977
- Sponsor's protocol ID
- PR-CBT-2019040-2F
- Status last verified
- Feb 2024
- First submitted
- 24 Dec 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06255977
- Acronym / sponsor ID
- PR-CBT-2019040-2F
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- SDM Bio Service Inc.
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intracerebral hemorrhage (ICH) is a devastating form of cerebrovascular disease for which there are no approved therapeutics that improve outcomes. Apolipoprotein E (apoE) has emerged as a promising therapeutic target given its isoform-specific neuroprotective properties and ability to modulate neuroinflammatory responses. We developed a 5-amino acid peptide, CN-105, that mimics the polar face of the apoE helical domain involved in receptor interactions, readily crosses the blood-brain barrier, and improves outcomes in well-established preclinical ICH models. In the current study, aim to assess the safety and the efficacy of CN-105 after administration for three consecutive days in participants with acute supratentorial ICH at three different dosages.
Detailed description
Inclusion Patients with spontaneous acute supratentorial intracerebral hemorrhage confirmed by CT，age 30 to 80 years，Intravenous infusion with CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours。
Blood samples for protein markers will be collected and detected at screening, 48 h(D3), and 120 h(D6) after the first dose:
The sample size is 240.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Control: placebo | Placebo comparator | Drug: CN-105Intravenous infusion with placebo（same volume of saline） every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of placebo（same volume of saline） will be administered as a slow IV bolus over 30 minutes. |
| Experimental: CN-105 peptide for injection 0.1 mg/kg | Experimental | Drug: CN-105Intravenous infusion with 0.1 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes. |
| Experimental:CN-105 peptide for injection 0.3 mg/kg | Experimental | Drug: CN-105Intravenous infusion with 0.3 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes. |
| Experimental: CN-105 peptide for injection 1.0 mg/kg | Experimental | Drug: CN-105Intravenous infusion with 1.0 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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, such as 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
Key exclusion criteria (25 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CN-105Also: CN-105peptideInjection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes. | Drug | Experimental: CN-105 peptide for injection 0.1 mg/kg, Experimental: CN-105 peptide for injection 1.0 mg/kg, Experimental:CN-105 peptide for injection 0.3 mg/kg, Placebo Control: placebo |
Primary outcome
AEs
Time frame: 90±7 days
Number and severity of AEs throughout the duration of the study;
SAEs
Time frame: 90±7 days
Number and severity of SAEs throughout the duration of the study;
Treatment-related mortality;
Time frame: 90±7 days
Treatment-related mortality throughout the duration of the study;
Deaths
Time frame: Day14, Day30,Day90
Rate of mortality at 14-day, 30-day, and 90-day ;
Incidence of cerebritis, meningitis, ventriculitis;
Time frame: 90±7 days
Incidence of cerebritis, meningitis, ventriculitis throughout the duration of the study;
Incidence of systemic infection associated with intracerebral hemorrhage
Time frame: 90±7 days
Incidence of systemic infection associated with intracerebral hemorrhage throughout the duration of the study;
The incidence of hematoma extension
Time frame: 24-48 hour （Day2~Day3）
The incidence of hematoma extension in 24-48 h after the first dose of study drug administration relative to baseline；
8 secondary outcomes
Modified Rankin Scale(mRS)
Time frame: Day90
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 90±7 days
contrast head CT to evaluate progression of perihematomal edema;
Time frame: screening, 24hour (Day2), 48hour (Day3) and 120hour (Day6),Day14
Modified Rankin Scale(mRS)
Time frame: Day30
Glasgow Coma Scale (GCS)
Time frame: Day3, Day14
Barthel Index assessment
Time frame: Day14, Day30, Day90
Montreal Cognitive Assessment (MoCA)
Time frame: Day2, Day30
MRI to evaluate the severity of neuronal injury and determine the progression of perihematomal edema respectively ；
Time frame: screening, 48hour (Day3), 120hour (Day6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
Related trials for Intracerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shuya Li, Study Director study director
IRB of Beijing Tiantan Hospital,Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CN-105 in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yongjun Wang, Study Director (13911172565, yongjunwang111@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: 90±7 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.