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    Summary
    EudraCT Number:2020-005931-58
    Sponsor's Protocol Code Number:APHP200043
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-005931-58
    A.3Full title of the trial
    ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis
    ACTIVE : Evaluation de l'acide tranexamique et de la terlipressine pour le traitement initial d'urgence de l'hémoptysie légère à sévère
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis
    ACTIVE : Evaluation de l'acide tranexamique et de la terlipressine pour le traitement initial d'urgence de l'hémoptysie légère à sévère
    A.3.2Name or abbreviated title of the trial where available
    ACTIVE
    ACTIVE
    A.4.1Sponsor's protocol code numberAPHP200043
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0144841722
    B.5.5Fax number0144841701
    B.5.6E-mailkarine.goude@aphp.fr
    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 Yes
    D.2.1.1.1Trade name GLYPRESSINE 1 mg/5 mL, poudre et solvant pour solution injectable (I.V.)
    D.2.1.1.2Name of the Marketing Authorisation holderFERRING SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERLIPRESSIN
    D.3.9.1CAS number 14636-12-5
    D.3.9.3Other descriptive nameTerlipressin acetate
    D.3.9.4EV Substance CodeSUB10927MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name ACIDE TRANEXAMIQUE MYLAN 0,5 g/ 5 mL, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRANEXAMIC ACID
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hemoptysis, whatever the cause, with the exception of cystic fibrosis
    Hémoptysie, quelle qu'en soit la cause, à l'exception de la mucoviscidose
    E.1.1.1Medical condition in easily understood language
    Hemoptysis, whatever the cause, with the exception of cystic fibrosis
    Hémoptysie, quelle qu'en soit la cause, à l'exception de la mucoviscidose
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess efficacy of inhaled TXA and inhaled TER versus placebo (normal saline) in immediate control of mild to severe hemoptysis within the first 5 days of hospitalization.
    L'objectif principal est d'évaluer l'efficacité de la TXA inhalée et de la TER inhalée par rapport au placebo (solution saline normale) dans le contrôle immédiat de l'hémoptysie légère à sévère dans les 5 premiers jours d'hospitalisation.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare active treatments (TXA and TER) to placebo (pairwise comparison) on the following parameters:
    - Complete resolution of hemoptysis
    - Partial resolution of hemoptysis
    - 30-day hemoptysis recurrence rate
    - Total volume of hemoptysis
    - Need and time of invasive procedure such as bronchial arterial endovascular embolization, mechanical ventilation,
    - Safety
    - Hospital mortality
    - 30-day mortality
    Using a hierarchical analysis, the comparison between TXA and TER will be tested once superiority on efficacy of both inhaled TXA and TER vs placebo is demonstrated. The above secondary objectives will then be assessed for the comparison of TXA versus TER.
    The identification of risk factors for hemoptysis recurrences will also be assessed.
    Les objectifs secondaires consistent à comparer les traitements actifs (TXA et TER) à un placebo (comparaison par paires) sur les paramètres suivants :
    - Résolution complète de l'hémoptysie
    - Résolution partielle de l'hémoptysie
    - Taux de récidive de l'hémoptysie à 30 jours
    - Volume total de l'hémoptysie
    - Nécessité et durée d'une procédure invasive telle que l'embolisation endovasculaire artérielle bronchique, ventilation mécanique,
    - La sécurité
    - Mortalité hospitalière
    - Mortalité à 30 jours
    En utilisant une analyse hiérarchique, la comparaison entre TXA et TER sera testée une fois que la supériorité de l'efficacité de TXA et TER inhalés par rapport au placebo sera démontrée. Les objectifs secondaires ci-dessus seront ensuite évalués pour la comparaison entre la TXA et la TER.
    L'identification des facteurs de risque de récidive de l'hémoptysie sera également évaluée.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients over 18 years, under 90 years
    - Mild to severe hemoptysis that has been going on for less than 72 hours
    - Total expectorate blood ranging from 50 ml to 200 ml
    - Admission in emergency department or ICU for less than 12 hours
    - Social security affiliation
    - Signed informed consent
    - For child-bearing aged women, efficient contraception
    - Patients de plus de 18 ans, de moins de 90 ans
    - Hémoptysie légère à sévère qui dure depuis moins de 72 heures
    - Sang expectoré total allant de 50 ml à 200 ml
    - Admission aux urgences ou aux soins intensifs pendant moins de 12 heures
    - Affiliation à la sécurité sociale
    - Consentement éclairé signé.
    - Pour les femmes en âge de procréer, une contraception efficace
    E.4Principal exclusion criteria
    - Need for mechanical ventilation
    - Cystic fibrosis
    - Pregnancy or breast feeding
    - Contraindication for contrast agents injection (renal failure with creatinin clearance < 30ml/min, know allergy to contrast agents injection)
    - Absolute need for anticoagulant treatment at curative dosage (recent venous thrombo-embolism in the 6 past months)
    - Known hypersensitivity to TXA or TER or one of its excipients
    - Contraindication to TXA or TER therapy :
    * acute myocardial infarction in the 6 past months,
    * intrathecal injection in the 3 past months,
    * seizure in the past 3 months
    - Participation in another interventional study or being in the exclusion period at the end of a previous study
    - Patient under tutorship or / guardianship, and incapable to give informed consent
    - Nécessité d'une ventilation mécanique
    - Mucoviscidose
    - Grossesse ou allaitement
    - Contre-indication à l'injection d'agents de contraste (insuffisance rénale avec clairance de la créatinine < 30mL/min, allergie connue à l'injection d'agents de contraste)
    - Nécessité absolue d'un traitement anticoagulant à dose curative (thrombo-embolie veineuse récente au cours des 6 derniers mois)
    - Hypersensibilité connue à la TXA ou à la TER ou à l'un de ses excipients
    - Contre-indication au traitement TXA ou TER :
    * infarctus aigu du myocarde au cours des 6 derniers mois,
    * injection intrathécale au cours des 3 derniers mois,
    * attaque/convulsion au cours des 3 derniers mois
    - La participation à une autre étude interventionnelle ou le fait d'être dans la période d'exclusion à la fin d'une étude précédente.
    - Patient sous tutelle et/ou curatelle, et incapable de donner son consentement éclairé
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point is defined as the proportion of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure. A complete resolution of hemoptysis is defined by absence of recurrence within 5 days; partial resolution is defined as hemoptysis recurrence < 50 mL within the first 5 days.
    Le critère d'évaluation principal est défini comme la proportion de patients présentant une résolution complète ou partielle de l'hémoptysie sans recours à une quelconque procédure interventionnelle. Une résolution complète de l'hémoptysie est définie par l'absence de récidive dans les 5 jours ; une résolution partielle est définie par une récidive de l'hémoptysie < 50 ml dans les 5 premiers jours.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days
    5 jours
    E.5.2Secondary end point(s)
    For each treatment group, the following endpoints will be assessed:
    - Rate of complete resolution of hemoptysis within 5 days, as previously defined
    - Rate of partial resolution of hemoptysis defined as recurrence < 50 mL within 5 days, as previously defined
    - Proportion of patients with total volume of hemoptysis < 200 mL within 5 days
    - Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization) within 5 days
    - Rate of patients who need a mechanical ventilation within 5 days
    - Time between hospital admission and endovascular treatment
    - In-hospital mortality
    - 30-day rate of patients with hemoptysis recurrence
    - 30-day mortality
    - Rate of specific adverse events : acute myocardial ischemia, symptomatic venous thromboembolism, hyponatremia (<130 mmol/L), bronchospasm (defined by the need of short-acting bronchodilatator).
    Anticipated candidate’s variables for the assessment of the hemoptysis recurrence riskinclude the followings: age, sex, baseline expectorated blood volume, cause of hemoptysis, previous hemoptysis, coagulation disorders, need in mechanical ventilation, treatment group.
    Pour chaque groupe de traitement, les paramètres suivants seront évalués :
    - Taux de résolution complète de l'hémoptysie dans les 5 jours, tel que défini précédemment
    - Taux de résolution partielle de l'hémoptysie définie comme une récidive < 50 ml dans les 5 jours,
    - Proportion de patients présentant un volume total d'hémoptysie < 200 ml dans les 5 jours
    - Taux de patients qui ont besoin d'un traitement endovasculaire (embolisation endovasculaire artérielle bronchique) dans les 5 jours
    - Taux de patients qui ont besoin d'une ventilation mécanique dans les 5 jours
    - Délai entre l'admission à l'hôpital et le traitement endovasculaire
    - Mortalité hospitalière
    - Taux de récidive de l'hémoptysie à 30 jours
    - Mortalité à 30 jours
    - Taux d'effets indésirables spécifiques : ischémie myocardique aiguë, thromboembolie veineuse symptomatique, hyponatrémie (<130 mmol/L), bronchospasme (défini par la nécessité d'un bronchodilatateur à courte durée d'action).
    Les variables prévues pour l'évaluation du risque de récidive d'hémoptysie sont les suivantes: âge, sexe, volume sanguin expectoré au départ, cause de l'hémoptysie, hémoptysie antérieure, troubles de la coagulation, besoin de ventilation mécanique, groupe de traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 jours
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 trial3
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    LVSL
    LVSL
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months25
    E.8.9.1In the Member State concerned days
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    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 state315
    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
    Aucun
    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 Decision2021-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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