- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168581
A Proof of Concept Study to Evaluate CN-105 in ICH Patients (CATCH)
A Proof of Concept Study to Evaluate Administration of CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage
A multicenter, open-label phase 2a trial of CN-105 in patients with supratentorial intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of symptom onset. Eligible participants (approximately 60) will receive CN-105 administered intravenously (IV) for a 30-minute infusion every 6 hours for up to a maximum of 3 days (13 doses) or until discharge (if earlier than 3 days). Participants will be monitored daily throughout the Treatment phase of the study (up to a maximum of 5 days) and will receive standard-of-care treatment for the duration of the study. Additional protocol assessments will be required during the Treatment phase. After discharge from the hospital, participants will enter a 3-month Follow-up phase, with a clinic visit at 30 days and a follow-up telephone interview with telephone-validated Modified Rankin Scale (mRS) at 90 days after first dose of study agent.
Funding Source - FDA OOPD
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- A.B. Chandler Medical Center-University of Kentucky
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North Carolina
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Durham, North Carolina, United States, 27709
- Duke University Health System
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Winston-Salem, North Carolina, United States, 27103
- Wake Forest Baptist Health
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Health Systems
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Is male or female, age 30 to 80 years, inclusive.
- Has a confirmed diagnosis of spontaneous supratentorial ICH.
- 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 an interpretable and measurable diagnostic CT scan.
- Has a Glasgow Coma Scale (GCS) score ≥ 5 on presentation
- Has a National Institutes of Health Stroke Scale (NIHSS) score ≥ 4.
- Has systolic BP (SBP) < 200 mm Hg at enrollment.
Exclusion Criteria:
- Is pregnant or lactating.
- Has a temperature greater than 38.5°C at Screening.
- Has ICH resulting from trauma.
- Has infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy).
- Has primary intraventricular hemorrhage deemed to be at high risk for obstructive hydrocephalus, or extra-axial (ie, subarachnoid or subdural) extension of hemorrhage.
- Has radiographic evidence of underlying tumor.
- Has an unstable mass or evolving intracerebral compartment syndrome.
- Has a ruptured aneurysm, arteriovenous malformation, or vascular anomaly.
- Has a platelet count < 100,000/mL.
- Has an international normalized ratio (INR) < 1.6 or irreversible coagulopathy either due to medical condition or detected before screening.
- 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.
- Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which, in the opinion of the investigator, unacceptably increases the individual's risk by participating in the study.
- Concomitant enrollment in another interventional study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CN-105
All eligible subjects will receive study drug, CN-105
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Patients with supratentorial intracerebral hemorrhage (ICH) will be evaluated for eligibility within 12 hours of symptom onset.
Eligible participants will receive CN-105 administered intravenously (IV) for a 30 -minute infusion every 6 hours for up to a maximum of 3 days (13 doses) or until discharge (if earlier than 3 days)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CN-105 safety assessment
Time Frame: 90 days
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Number and severity of AEs throughout the duration of the study
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90 days
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Mortality
Time Frame: 30 days
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Record In-hospital 30-day mortality
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30 days
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Mortality
Time Frame: 90 days
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record 90-day mortality
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90 days
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In-hospital neurological deterioration
Time Frame: 30 days
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Increase of National Institutes of Health Stroke Scale (NIHSS), > 2 from baseline, persisting more than 24 hours, and unrelated to sedation.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in 30-day mortality
Time Frame: 30 days
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Compare participants treated with CN-105 with matched controls
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30 days
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Improvement in 30-day functional outcomes
Time Frame: 30 days
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Compare participants treated with CN-105 with matched controls
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30 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory CT to evaluate progression of edema
Time Frame: 30 days
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To investigate feasibility of noncontrast head computed tomography (CT) as a radiographic surrogate to evaluate progression of perihematomal edema
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30 days
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Exploratory MRI to evaluate progression of edema
Time Frame: 30 days
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To investigate feasibility magnetic resonance imaging (MRI) radiographic surrogate measures to evaluate progression of perihematomal edema
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30 days
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Exploratory neuroinflammatory biomarker assessment to evaluate progression of edema
Time Frame: 90 days
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To investigate feasibility of using serial biochemical markers of neuroinflammation and neuronal injury as a surrogate measure of perihematomal edema and clinical outcome in the setting of spontaneous ICH
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90 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael L James, MD, Duke University
Publications and helpful links
General Publications
- Li S, Wangqin R, Meng X, Li H, Wang Y, Wang H, Laskowitz D, Chen X, Wang Y. Tolerability and Pharmacokinetics of Single Escalating and Repeated Doses of CN-105 in Healthy Participants. Clin Ther. 2022 May;44(5):744-754. doi: 10.1016/j.clinthera.2022.03.006. Epub 2022 May 11.
- Guptill JT, Raja SM, Boakye-Agyeman F, Noveck R, Ramey S, Tu TM, Laskowitz DT. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Escalating Dose and Repeated Doses of CN-105 in Healthy Adult Subjects. J Clin Pharmacol. 2017 Jun;57(6):770-776. doi: 10.1002/jcph.853. Epub 2016 Dec 19.
- Lei B, James ML, Liu J, Zhou G, Venkatraman TN, Lascola CD, Acheson SK, Dubois LG, Laskowitz DT, Wang H. Neuroprotective pentapeptide CN-105 improves functional and histological outcomes in a murine model of intracerebral hemorrhage. Sci Rep. 2016 Oct 7;6:34834. doi: 10.1038/srep34834. Erratum In: Sci Rep. 2017 Jan 05;7:39580. Sci Rep. 2020 Apr 20;10(1):6898.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CATCH
- 5R01FD005387-02 (U.S. FDA Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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