CATCH: A Proof of Concept Study to Evaluate CN-105 in ICH Patients

Sponsor

AegisCN LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03168581

Collaborator

Duke Clinical Research Institute (Other), PharPoint Research, Inc. (Industry)

Enrollment

Locations

Arm

28.9

Actual Duration (Months)

7.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage	Drug: CN-105	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Proof of Concept Study to Evaluate Administration of CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage

Actual Study Start Date :

Aug 28, 2017

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Jan 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CN-105 All eligible subjects will receive study drug, CN-105	Drug: CN-105 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)

Arm

Intervention/Treatment

Experimental: CN-105

All eligible subjects will receive study drug, CN-105

Drug: CN-105

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)

Outcome Measures

Primary Outcome Measures

CN-105 safety assessment [90 days]
Number and severity of AEs throughout the duration of the study
Mortality [30 days]
Record In-hospital 30-day mortality
Mortality [90 days]
record 90-day mortality
In-hospital neurological deterioration [30 days]
Increase of National Institutes of Health Stroke Scale (NIHSS), > 2 from baseline, persisting more than 24 hours, and unrelated to sedation.

Secondary Outcome Measures

Improvement in 30-day mortality [30 days]
Compare participants treated with CN-105 with matched controls
Improvement in 30-day functional outcomes [30 days]
Compare participants treated with CN-105 with matched controls

Other Outcome Measures

Exploratory CT to evaluate progression of edema [30 days]
To investigate feasibility of noncontrast head computed tomography (CT) as a radiographic surrogate to evaluate progression of perihematomal edema
Exploratory MRI to evaluate progression of edema [30 days]
To investigate feasibility magnetic resonance imaging (MRI) radiographic surrogate measures to evaluate progression of perihematomal edema
Exploratory neuroinflammatory biomarker assessment to evaluate progression of edema [90 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	A.B. Chandler Medical Center-University of Kentucky	Lexington	Kentucky	United States	40536
2	Duke University Health System	Durham	North Carolina	United States	27709
3	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27103
4	Medical University of South Carolina	Charleston	South Carolina	United States	29425
5	University of Virginia Health Systems	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

AegisCN LLC
Duke Clinical Research Institute
PharPoint Research, Inc.

Investigators

Principal Investigator: Michael L James, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

AegisCN LLC

ClinicalTrials.gov Identifier:

NCT03168581

Other Study ID Numbers:

CATCH
5R01FD005387-02

First Posted:

May 30, 2017

Last Update Posted:

Mar 11, 2020

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Mar 11, 2020