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    Summary
    EudraCT Number:2021-006694-39
    Sponsor's Protocol Code Number:ASF-CP02-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-03-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2021-006694-39
    A.3Full title of the trial
    An open-label, historical cohort control study to evaluate the safety and tolerability of AF-16 in patients with cerebral oedema caused by traumatic brain injury (TBI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the safety and tolerability of AF-16 in patients with cerebral oedema caused by traumatic brain injury (TBI)
    A.4.1Sponsor's protocol code numberASF-CP02-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLantmännen Medical AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLantmännen Medical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLantmännen Medical AB
    B.5.2Functional name of contact pointLars Franzén
    B.5.3 Address:
    B.5.3.1Street AddressBox 30192
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE 104 25
    B.5.3.4CountrySweden
    B.5.4Telephone number004670214 88 41
    B.5.6E-maillars.franzen@lantmannen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AF-16
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number 188585-60-6
    D.3.9.3Other descriptive nameAF-16
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cerebral oedema caused by traumatic brain injury (TBI)
    E.1.1.1Medical condition in easily understood language
    Build up of fluid in the brain caused by traumatic brain injury.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10060690
    E.1.2Term Traumatic brain injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10008127
    E.1.2Term Cerebral oedema
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    • 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.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    • 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.
    • 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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)
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    • Frequency and severity of adverse events (AEs) in patients treated with AF-16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously from enrolment (Day 1) until Follow-up on Day 30.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Changes in vital signs, physical examination results, electrocardiogram, clinical chemistry, hematology, coagulation, and hormonal values during the study period
    • TIL area under the curve (AUC) from Day 1 through Day 5 or earlier in the case of early discontinuation
    • Total time spent with insults of ICP >20 mm Hg lasting longer than 5 minutes from the start of AF-16 treatment to the end of AF-16 treatment (ie, Day 5 or earlier in the case of early discontinuation)
    • ICP AUC24 from Day 1 through Day 5 or earlier in the case of early discontinuation
    • Use of third-tier therapies/high-TIL treatments (temperature <35℃, secondary decompressive craniotomy, metabolic suppression [eg, with barbiturates]), or incidence of death
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes in vital signs, ECG, physical examination, safety laboratory values will be followed on a daily basis during study days 1-7, on Day 14 and on Day 30.
    Hormonal values will be measured at enrolment and on days 7,14 and 30.
    TIL and its subitems will be reported every 24 hours, ICP will be reported every 2 hours.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    An open-label, historical cohort control study.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Historical controls with prospectively collected data from the CENTER-TBI study
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study ends with the last scheduled visit or Day 30 ± 4 days of the last patient participating in the study, whichever is earlier.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject has been admitted to the hospital because of a traumatic brain injury (TBI) within 12 hours of injury
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None, patients will receive continuation of standard of care procedures as per the treating facility.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-16
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