Study to assess the safety and tolerability of AF-16 in patients with cerebral oedema caused by traumatic brain injury (TBI)

Phase 1

• Conditions: Cerebral oedema caused by traumatic brain injury (TBI); MedDRA version: 20.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10008127Term: Cerebral oedemaSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-006694-39-DE
• Lead Sponsor: antmännen Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-25
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Is a male or female adult = 18 through = 85 years of age
2. Has been admitted to the hospital because of a TBI within 12 hours of injury
3. Has a GCS score between 4 and 12 (inclusive) that requires ICP monitoring
4. Shows signs of cerebral edema (brain swelling) on the CT scan at admission
5. Has ICP monitoring in place before first dose of AF-16
6. Has a non-provoked elevation of ICP above the threshold value of 15 mm Hg during the 1 hour before the administration of AF-16
7. Has a systolic blood pressure = 100 mm Hg
8. Has provided signed informed consent (through the patient’s representative according to local regulatory requirements and in accordance with the study protocol)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Has a completely effaced basal cistern and midline shift > 5 mm on the admission CT scan unless the midline shift is a consequence of a focal lesion
2. Has received surgical interventions to manage ICP elevation before enrollment unless:
i. ICP monitoring continues postoperatively, and
ii. ICP > 15 mm Hg in the postoperative period that is not due to re-accumulation of a surgical lesion
3. Is planned to have decompressive craniectomy before enrollment
4. Has an extradural hemorrhage evaluated to be the sole cause of ICP increase without signs of cerebral edema
5. Has extensive thoracic, abdominal, or pelvic trauma that requires surgical interventions
6. Has a penetrating head injury (eg, missile, stab wound)
7. Has associated spinal injury
8. Is not expected to survive > 24 hours after admission
9. Has had a cardiopulmonary resuscitation performed post-injury
10. Has continuous bleeding that is likely to require multiple transfusions (> 4 units of red blood cells)
11. Is in a coma suspected to be primarily due to other causes than head injury (eg, drug overdose)
12. Has known or CT scan evidence of preexisting major cerebral damage
13. Has a known allergy to any of the AF-16 components
14. Is a pregnant female*
15. Is otherwise unsuitable for study participation as judged by the investigator
*as evidenced by a positive human chorionic gonadotropin (hCG) test in the urine. A pregnancy test will be conducted in all women
potentially being of childbearing potential. For the purpose of this study, this includes all women below 60 years. The result of a
pregnancy test will not be revealed to the representative giving consent to study participation on behalf of the woman.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective:<br>• To evaluate the safety and tolerability of 5 days of antisecretory factor AF-16 treatment in patients with cerebral edema (brain swelling) because of TBI.;Secondary Objective: Secondary Objectives:<br>• To explore the efficacy of 5 days of AF-16 treatment compared with historical controls as measured by intracranial pressure (ICP) in patients with cerebral edema (brain swelling) because of TBI.<br>• To explore the use of concomitant therapies (therapy intensity level [TIL]) after 5 days of AF-16 treatment compared with historical controls in patients with cerebral edema (brain swelling) because of TBI.;Primary end point(s): Primary endpoint:<br>• Frequency and severity of adverse events (AEs) in patients treated with AF-16;Timepoint(s) of evaluation of this end point: Continuously from enrolment (Day 1) until Follow-up on Day 30.