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Evaluation of CN-105 in Subject With Acute Supratentorial Intracerebral Hemorrhage (S-CATCH)

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ClinicalTrials.gov Identifier: NCT03711903
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Aegis CN LLC funding , and Singapore Clinical research institute for study monitoring
Information provided by (Responsible Party):
National Neuroscience Institute

Brief Summary:
Phase 2, randomized, double-blind, placebo controlled study to evaluate the administration of CN-105 in patients with supratentorial intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of symptom onset. Eligible participants (30 active participants and 30 control participants) will receive CN-105 or placebo 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 as outlined in Section 7.5. 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 mRS at 90 days after first dose of study agent.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Acetyl-Valine-Serine-Arginine-Arginine-Arginine-NH2 (Ac-VSRRR- NH2). Drug: 0.9% Sodium-chloride Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The treatment arm will be given CN 105 The placebo arm will be give 0/9% NaCl
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase 2, Randomized, Double Blind, Placebo , Controlled Study To Evaluate The Administration of CN-105 In Participants With Acute Supratentorial Intracerebral Hemorrhage
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Treatment arm
The study drug, CN-105, will be administered at 1.0 mg/kg every 6 + 2 hours. The calculated volumes of study agent will be removed from the vials and transferred to 250 mL of normal saline (0.9% sodium chloride injection, USP). The recorded weight at baseline will be used to determine the appropriate amount of CN-105 drug product to administer. Each dose of CN-105 or placebo will be administered as a slow IV bolus over 30 minutes.
Drug: Acetyl-Valine-Serine-Arginine-Arginine-Arginine-NH2 (Ac-VSRRR- NH2).
The study drug, CN-105 is supplied in amber glass vials containing 4 mL of a concentrated 12.5-mg/mL clear-to-slightly-yellow solution.
Other Name: CN105

Placebo Comparator: Placebo arm
The Placebo arm will be given 0.9% NaCL
Drug: 0.9% Sodium-chloride
normal saline




Primary Outcome Measures :
  1. adverse event [ Time Frame: 0-12 hours ]
    any untoward medical occurrence associated with the use of the drug in a participant

  2. adverse event [ Time Frame: 24 hour ]
    untoward medical occurrence associated with the use of the study drug whether considered related or not

  3. adverse event [ Time Frame: 48 hour ]
    untoward medical occurrence associated with the use of the study drug whether considered related or not

  4. adverse event [ Time Frame: 72 hour ]
    untoward medical occurrence associated with the use of the study drug whether considered related or not

  5. adverse event [ Time Frame: 96 hour ]
    untoward medical occurrence associated wtth the use of study drug whether considered related or not

  6. adverse event [ Time Frame: 120 hour ]
    untoward medical occurrence associated wtth the use of study drug whether considered related or not

  7. adverse event [ Time Frame: 30 day ]
    untoward medical occurrence associated with the use of study drug whether considered related or not

  8. adverse event [ Time Frame: 90 day ]
    untoward medical occurrence associated with the use of study drug whether considered related or not

  9. GCS [ Time Frame: 0-12 hour ]
    score as per scale

  10. GCS [ Time Frame: 24H ]
    scored as per scale

  11. GCS [ Time Frame: 48 hours ]
    scored as per scale

  12. GCS [ Time Frame: 72 Hour ]
    scored as per scale

  13. GCS [ Time Frame: 96 hour ]
    scored as per scale

  14. GCS [ Time Frame: at 120 hour ]
    scored as per scale

  15. GCS [ Time Frame: at 30 day ]
    scored as per scale

  16. GCS [ Time Frame: at 90 day ]
    scored as per scale

  17. NIHSS [ Time Frame: 0- 12 hour ]
    scored as per assessment

  18. NIHSS [ Time Frame: 120 hour ]
    scored as per assessment

  19. NIHSS [ Time Frame: 24 hour ]
    scored as per assessment

  20. NIHSS [ Time Frame: 48 hour ]
    scored as per assessment

  21. NIHSS [ Time Frame: 72 hour ]
    scored as per assessment

  22. NIHSS [ Time Frame: 96 Hour ]
    scored as per assessment

  23. NIHSS score [ Time Frame: 30 day ]
    score as per assessment

  24. NIHSS score [ Time Frame: 90 day ]
    score as per assessment

  25. Severe adverse event [ Time Frame: 48 hour ]
    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  26. Severe adverse event [ Time Frame: 0-12 hour ]
    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  27. Severe adverse event [ Time Frame: 72 hour ]
    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  28. Severe adverse event [ Time Frame: 96 hour ]
    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  29. Severe adverse event [ Time Frame: at 90 day ]
    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  30. Severe adverse event [ Time Frame: at 120 hour ]
    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  31. Severe adverse event [ Time Frame: at 30 day ]
    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  32. systemic infection [ Time Frame: 0-12 hour ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  33. systemic infection [ Time Frame: 24 hour ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  34. systemic infection [ Time Frame: 48 hour ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  35. systemic infection [ Time Frame: 72 hour ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  36. systemic infection [ Time Frame: 96 hours ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  37. systemic infection [ Time Frame: 120 hours ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  38. systemic infection [ Time Frame: 30 day ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  39. systemic infection [ Time Frame: 90 day ]
    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  40. Brain CT scan [ Time Frame: 0-12 hour ]
    evaluate hematoma expansion

  41. Brain CT scan [ Time Frame: 48 Hour ]
    evaluate hematoma expansion

  42. Brain CT scan [ Time Frame: 96 hour ]
    evaluate hematoma expansion

  43. Brain CT scan [ Time Frame: 120 hour ]
    evaluate hematoma expansion

  44. Brain CT scan [ Time Frame: 24 hour ]
    evaluate hematoma expansion

  45. presence of CNS infection [ Time Frame: 24 hour ]
    meningitis, cerebritis, ventriculitis

  46. presence of CNS infection [ Time Frame: 72 hours ]
    meningitis, cerebritis, ventriculitis

  47. presence of CNS infection [ Time Frame: 0-12 hour ]
    meningitis, cerebritis, ventriculitis

  48. presence of CNS infection [ Time Frame: 48 hours ]
    meningitis, cerebritis, ventriculitis

  49. presence of CNS infection [ Time Frame: 120 hour ]
    meningitis, cerebritis, ventriculitis

  50. presence of CNS infection [ Time Frame: 96 hour ]
    meningitis, cerebritis, ventriculitis

  51. presence of CNS infection [ Time Frame: 30 day ]
    meningitis, cerebritis, ventriculitis

  52. presence of CNS infection [ Time Frame: 90 day ]
    meningitis, cerebritis, ventriculitis

  53. Mortality [ Time Frame: 0-12 hour ]
    death related or unrelated to the study drug

  54. Mortality [ Time Frame: 48 hour ]
    death related or unrelated to the study drug

  55. Mortality [ Time Frame: 72 hour ]
    death related or unrelated to the study drug

  56. Mortality [ Time Frame: 24 hour ]
    death related or unrelated to the study drug

  57. Mortality [ Time Frame: 96 hour ]
    death related or unrelated to the study drug

  58. Mortality [ Time Frame: 30- day ]
    occurrence of death related or not related to the use of the study drug

  59. Mortality [ Time Frame: 90 -day ]
    occurrence of death related or not related to the use of the study drug


Secondary Outcome Measures :
  1. outcome as assessed by mRS [ Time Frame: 120 hour ]
    MRS scoring

  2. functional outcome as assessed by mRS [ Time Frame: 30 Day ]
    MRS scoring

  3. outcome as assessed by mRS [ Time Frame: 90Day ]
    MRS scoring

  4. cognitive assessment [ Time Frame: 120 Hour ]
    Montreal cognitive assessment

  5. Discharge disposition [ Time Frame: day 90 ]
    The place where the patient was discharge -either home, nursing home or rehabilitation care facilities

  6. cognitive assessment [ Time Frame: 30 day ]
    Montreal cognitive assessment

  7. cognitive assessment [ Time Frame: 90 day ]
    Montreal cognitive assessment

  8. Barthel index [ Time Frame: 120 hour ]
    score as per assessment

  9. Barthel index [ Time Frame: 30 day ]
    score as per assessment

  10. Barthel index [ Time Frame: 90 day ]
    score as per assessment


Other Outcome Measures:
  1. biomarkers of brain injury [ Time Frame: 0-12 hour ]
    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  2. biomarkers of brain injury [ Time Frame: 24 hour ]
    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  3. biomarkers of brain injury [ Time Frame: 48 hour ]
    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  4. biomarkers of brain injury [ Time Frame: 72 hour ]
    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  5. biomarkers of brain injury [ Time Frame: 120 hour ]
    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Is male or female, age 30 to 80 years, inclusive.
  4. Has a confirmed diagnosis of spontaneous supratentorial ICH.
  5. 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.
  6. Has an interpretable and measurable diagnostic CT scan.
  7. Has a GCS score ≥ 5 on presentation (Appendix D)
  8. Has a National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 (Appendix C).
  9. Has systolic BP (SBP) < 200 mm Hg at enrollment.

Exclusion Criteria:

1Known pregnancy and lactation 2.Has a temperature greater than 38.5°C at Screening. 3.ICH known to result from trauma. 4.Evidence of infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy) severely limiting the recovery potential of the patient in the opinion of the investigator.

5.Evidence of primary intraventricular hemorrhage deemed to be at high risk for obstructive hydrocephalus, in the opinion of the investigator or evidence of extra-axial (i.e., subarachnoid or subdural) extension of hemorrhage severely limiting the recovery potential of the patient in the opinion of the investigator.

6.Radiographic evidence of underlying tumor. 7.Known unstable mass or active radiographic evidence and symptoms of herniation syndromes severely limiting the recovery potential of the patient in the opinion of the investigator.

8.Known ruptured aneurysm, arteriovenous malformation, or vascular anomaly. 9.Has a platelet count < 100,000/mL. 10.Has an international normalized ratio (INR) > 1.5 or irreversible coagulopathy either due to medical condition or detected before screening.

11.Is taking new oral anticoagulants (NOACS) 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.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.

15.Concomitant enrollment in another interventional study.


Publications of Results:

Other Publications:

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Responsible Party: National Neuroscience Institute
ClinicalTrials.gov Identifier: NCT03711903     History of Changes
Other Study ID Numbers: S-CATCH
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases