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    Summary
    EudraCT Number:2019-003756-37
    Sponsor's Protocol Code Number:ANT-005
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-21
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-003756-37
    A.3Full title of the trial
    A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active-Controlled, Dose-Ranging Study to Compare the Efficacy and Safety of i.v. MAA868 and s.c. Enoxaparin in Adult Patients Undergoing Elective Unilateral Total Knee Arthroplasty
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare study drug MAA868 with standard of care (enoxaparin) in adults undergoing knee surgery
    A.4.1Sponsor's protocol code numberANT-005
    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 SponsorAnthos Therapeutics
    B.1.3.4CountryUnited States
    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 supportAnthos Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnthos Therapeutics, Inc.
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address55 Cambridge Parkway
    B.5.3.2Town/ cityCambridge / MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617-430-6940
    B.5.6E-mailinfo@anthostherapeutics.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.3.1Product nameAbelacimab
    D.3.2Product code MAA868
    D.3.4Pharmaceutical form Concentrate for 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 INNAbelacimab
    D.3.9.2Current sponsor codeMAA868
    D.3.9.3Other descriptive nameMAA868
    D.3.9.4EV Substance CodeSUB188882
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman monoclonal antibody against human FXI
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.1Product nameEnoxaparin
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARIN
    D.3.9.1CAS number 9005-49-6
    D.3.9.4EV Substance CodeSUB21316
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Clexane
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Romania SRL
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    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.3.1Product nameEnoxaparin
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARIN
    D.3.9.1CAS number 9005-49-6
    D.3.9.4EV Substance CodeSUB21316
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Elective unilateral total knee arthroplasty
    E.1.1.1Medical condition in easily understood language
    Knee surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10023469
    E.1.2Term Knee arthroplasty
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess if at least one dose of MAA868 is non-inferior to enoxaparin 40 mg through Day 10 after randomization in terms of incidence of adjudicated total VTE in patients undergoing unilateral TKA.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of MAA868 relative to enoxaparin in terms of the incidence of major and clinically relevant non-major (CRNM) bleeding events through Day 10 and through Day 30.

    • To assess if at least one dose of MAA868 is non-inferior to enoxaparin 40 mg through Day 30 and Day 110 (EoS) in terms of the incidence of adjudicated total VTE in patients undergoing unilateral TKA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent before any study assessment is performed

    2. Male and female patients (≥ 18 years old and < 80 years old)

    3. Scheduled to undergo elective unilateral TKA

    4. Willing to comply with study requirements including venography at Day 10 ± 2 days

    5. Body weight between 50 kg and 130 kg inclusive

    6. aPTT, PT, INR within normal limits at screening
    E.4Principal exclusion criteria
    1. Use of other investigational drugs within 5 half-lives of enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer

    2. History of hypersensitivity to any of the study drugs (including enoxaparin) or its excipients, to drugs of similar chemical classes or drugs issued from the same biologic origin or any contraindication listed in the label for enoxaparin

    3. Any medical condition requiring chronic antithrombotic therapy (e.g. atrial fibrillation, VTE, recent coronary intervention) with the exception of low dose aspirin ≤ 100 mg

    4. Known or suspected active bleeding at study entry

    5. Macroscopic hematuria or urine dipstick positive for blood 2+ or
    greater during the screening period

    6. Patients at increased risk of bleeding because of a history of increased bleeding tendency (e.g.., history of bleeding diathesis, known active gastrointestinal lesions such as angiodysplasia or an endoscopically verified gastrointestinal ulcer or a history of gastrointestinal bleeding within the past year) or any other condition that in the opinion of the Investigator increases risk of bleeding or patients with a history of intracranial or intraocular bleeding

    7. Major surgery including brain, spinal, or ophthalmologic surgery within the past 6 months

    8. History of a traumatic spinal or epidural anesthesia or excessive intra- or direct postoperative bleeding

    9. Major trauma within the past 6 months

    10. History of VTE

    11. Malignancy within the past year, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated

    12. Myocardial infarction, stroke, or transient ischemic attack in the past 6 months

    13. Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg
    and/or diastolic blood pressure ≥ 100 mm Hg), based on up to 3
    readings at screening

    14. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2

    15. Clinically significant anemia during screening as defined by
    hemoglobin level < 10 g/dL for males and < 11 g/dL for females

    16. Platelet count <150,000/m3 at screening or a history of heparin-induced thrombocytopenia

    17. Unable to undergo venography due to a known allergy to the contrast agent, anticipated poor venous access, impaired renal function, or any other reason identified and specified by the Investigator

    18. Anticipated use of intermittent pneumatic compression devices post TKA procedure

    19. Liver dysfunction (ALT/AST >3x ULN or total bilirubin >2x ULN), diagnosis of liver cirrhosis, history of hepatic encephalopathy, esophageal varices, or portocaval shunt

    20. Positive test for human immunodeficiency virus (HIV), positive
    hepatitis B (hepatitis B surface antigen [HBsAg]) or hepatitis C (anti
    hepatitis C antibody [Anti-HCV] and confirmed by a positive HCV nucleic acid test) at Screening

    21. Clinically significant abnormal ECG, which precludes the patient from surgery, at screening as judged by the Investigator

    22. Recent (within the last 12 months) or current history of alcoholism or drug addiction

    23. Pregnant or nursing (lactating) women

    24. Women of child-bearing potential, defined as all women
    physiologically capable of becoming pregnant, unless they are using
    highly effective methods of contraception, which comply with the
    surgical intervention planned during the proposed clinical study, during use of study treatments and for 3 days after last treatment of
    enoxaparin and 110 days after administration of MAA868.

    25. Sexually active males must agree to use a condom during intercourse during their time in the study and should not father a child or donate sperm in this period.

    26. Significant illness which has not resolved within two (2) weeks prior to the start of the study drug

    27. Any illnesses or other medical conditions which may preclude
    patients from complying with study requirements

    28. Anticipated elective surgery (e.g., contralateral TKA) during the study period
    E.5 End points
    E.5.1Primary end point(s)
    • Occurrence of confirmed composite endpoint of asymptomatic DVT on the protocol required venography, confirmed symptomatic VTE (including confirmed symptomatic DVT of the leg, fatal or non-fatal PE), or unexplained death for which PE could not be ruled-out during treatment through Day 10.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 10
    E.5.2Secondary end point(s)
    1) Occurrence of confirmed composite endpoint of major bleeding and CRNM bleeding events through Day 10 and Day 30.

    2) Occurrence of confirmed composite endpoint of asymptomatic DVT on the protocol required venography, confirmed symptomatic VTE (including confirmed symptomatic DVT of the leg, fatal or non-fatal PE), or unexplained death for which PE could not be ruled-out during treatment through Day 30 and Day 110.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 10 - 30

    2) Day 30 - 110
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Latvia
    Lithuania
    Poland
    Russian Federation
    Ukraine
    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
    Last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 411
    F.4.2.2In the whole clinical trial 600
    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)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-12
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