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    The EU Clinical Trials Register currently displays   42867   clinical trials with a EudraCT protocol, of which   7062   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-001031-39
    Sponsor's Protocol Code Number:69HCL17_0018
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-19
    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 number2017-001031-39
    A.3Full title of the trial
    BABH Study: Efficacy and safety of bevacizumab on severe bleedings associated with Hemorrhagic Hereditary Telangiectasia (HHT). A National, randomized multicenter phase III study.
    Etude BABH - Efficacité et tolérance du bévacizumab pour le traitement des hémorragies sévères chez les patients porteurs de la maladie de Rendu-Osler.
    Etude nationale, randomisée, multicentrique de phase III.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BABH Study: Efficacy and safety of bevacizumab on severe bleedings associated with Hemorrhagic Hereditary Telangiectasia (HHT)
    Etude BABH - Efficacité et tolérance du bévacizumab pour le traitement des hémorragies sévères chez les patients porteurs de la maladie de Rendu-Osler.
    A.3.2Name or abbreviated title of the trial where available
    BABH
    BABH
    A.4.1Sponsor's protocol code number69HCL17_0018
    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 SponsorHospices Civils de Lyon
    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 supportFrench Ministry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointJustine Bricout
    B.5.3 Address:
    B.5.3.1Street Address3 QUAIS DES CELESTINS
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number472406829+33
    B.5.5Fax number472115190+33
    B.5.6E-maildrci_promo@chu-lyon.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 AVASTIN
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1390– EMA/OD/167/14
    D.3 Description of the IMP
    D.3.1Product nameBEVACIZUMAB
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hemorrhagic Hereditary Telangiectasia
    Rendu-Osler
    E.1.1.1Medical condition in easily understood language
    Hemorrhagic Hereditary Telangiectasia
    Rendu-Osler
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031132
    E.1.2Term Osler-Weber-Rendu disease
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate, 6 months after the beginning of the treatment, the efficacy of intraveinous bevacizumab (5 mg/kg/injection, administrated every 14 days, 6 times) on blood transfusions (number of units) in patients with HHT complicated by severe bleedings responsible for severe anemia.
    Evaluer l’efficacité, d’une série de 6 injections intraveineuses de bévacizumab, 6 mois après le début du traitement sur le nombre d’unité de globules rouges transfusés chez des patients porteurs de la maladie de Rendu Osler présentant des hémorragies sévères responsables d’anémie.
    E.2.2Secondary objectives of the trial
    1. To evaluate efficacy of treatment on hemoglobin levels 3 and 6 months after the beginning of the treatment.
    2. To evaluate efficacy on the evolution of other clinical parameters: epistaxis (frequency, duration and ESS), quality of life 3 to 6 months after the beginning of treatment, hospitalizations.
    3. To assess the safety of bevacizumab in HHT patients with severe hemorrhages.
    4. To evaluate the efficacy of bevacizumab on associated digestive vascular malformations in HHT patients with digestive bleeding (Endoscopy).
    5. To study the pharmacokinetics of bevacizumab in HHT patients with bleedings.
    1. Evaluer l’efficacité sur le taux d’hémoglobine à 3 et à 6 mois après le début du traitement
    2. Evaluer l’efficacité sur l’évolution d’autres paramètres cliniques : les épistaxis (fréquence, durée et score de sévérité « ESS »), la qualité de vie à 3 et à 6 mois après la fin du traitement (questionnaire SF-36) et le nombre d’hospitalisations
    3. Evaluer la tolérance du bévacizumab chez les patients avec des hémorragies sévères
    4. Evaluer l’efficacité du bévacizumab sur les MAV digestives par endoscopie chez des patients présentant des saignements digestifs extériorisés.
    5. Etudier la pharmacocinétique du bévacizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years.
    - Patients who have given their free informed and signed consent.
    - Patients affiliated to a social security scheme or similar.
    - Patients monitored for clinically confirmed HHT (presence of at least three Curaçao criteria) and / or with molecular biology confirmation.
    - Blood transfusions with the requirement for at least 3 units of blood in the 3-month period before study enrollment, related to epistaxis or digestive bleeding.
    - Age ≥ 18 ans.
    - Patient ayant donné leur consentement libre, éclairé et signé.
    - Patient affilié à un régime de sécurité sociale ou assimilé.
    - Patient suivi pour une maladie de Rendu-Osler confirmée cliniquement (présence d’au moins 3 critères de Curaçao) et/ou en biologie moléculaire.
    - Transfusion d’un minimum de 3 culots de globules rouges en rapport avec des épistaxis ou des saignements digestifs dans les 3 mois précédant l’inclusion.
    E.4Principal exclusion criteria
    - Pregnant or nursing (lactating) women or likely to become so in the course of the study.
    - Patients who are protected adults under the terms of the law (French Public Health Code).
    - Refusal to consent.
    - Patients for whom the diagnosis of HHT has not been confirmed clinically and / or by molecular biology study.
    - Active infection and/or fever>38°C
    - Participation in another clinical trial within 28 days prior to inclusion.
    - Hypersensitivity to the active substance or to any of the excipients.
    - Known hypersensitivity to products of Chinese hamster ovary cells (CHO) or other recombinant human or humanized antibodies.
    - Patients who have taken Avastin ® intravenously in the 6 months prior to inclusion.
    - Patients who have had a therapeutic endoscopy for gastrointestinal bleeding or ENT surgery for epistaxis will have to wait at least 3 months less after treatment to be included if bleeding persists.
    - Patients who had a surgery in the month prior inclusion or planned surgery within 6 months
    - Severe peripheral arterial disease with ulcerations
    - Unhealed wound
    - Femmes enceintes ou susceptibles de l’être pendant l’étude, ou en cours d’allaitement.
    -Patient majeur protégé selon les termes de la loi (Code de la santé Publique).
    -Refus de consentement.
    -Patient pour lequel le diagnostic de maladie de Rendu-Osler n’a pas été confirmé cliniquement ou/et en biologie moléculaire.
    -Fièvre > 38°C et/ou infection en cours.
    - Participation à un autre essai thérapeutique dans les 28 jours précédant l’inclusion.
    - Hypersensibilité connue au bévacizumab, à l’un des excipients de la solution d’Avastin ®, aux produits des cellules ovariennes de hamster chinois ou aux anticorps recombinant ou humanisés.
    - Patient ayant reçus une perfusion intraveineuse d’Avastin ® dans les 6 mois avant l’inclusion.
    - Patient ayant eu une endoscopie digestive curatrice pour des saignements digestifs.
    - Patient n’ayant plus d’épistaxis 3 mois après une intervention chirurgicale ORL pour des épistaxis.
    - Patient ayant eu une chirurgie dans le mois précédant l’inclusion ou une chirurgie planifiée dans les 6 mois après l’inclusion.
    - Maladie artérielle périphérique avec ulcération.
    - Plaie non cicatrisée.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients successful in both groups will be compared. Efficacy will be considered for a patient if the number of red blood cell transfusions is decreased by at least 50% between the 3 months-period (N1) before treatment and the period from the 3rd to 6th months (N2) after the beginning of treatment.
    Le pourcentage de patients ayant répondu au traitement dans chacun des groupes sera comparé. L’efficacité du bévacizumab est définie par une diminution de 50% des transfusions entre la période de 3 mois immédiatement avant le traitement et la période entre 3 et 6 mois après le début du traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    1.Hemoglobin levels measured before treatment (M0) and at 3 and 6 months.
    2. Criteria for clinical efficacy :
    - Evolution of the mean monthly epistaxis duration and frequency (number / month) before treatment, at 3 months and 6 months after the beginning of treatment. This criterion will be assessed on the basis of monitoring of epistaxis grids completed by the patient 3 months before treatment and for 6 months after starting treatment.
    - Changing the scores on the SF-36 quality of life and ESS questionnaire, between the start of treatment, 3 months and 6 months after starting treatment.
    3.Adverse events observed with repeated administration of bevacizumab: evaluation by collecting data at each visit, monitoring nosebleeds, bleeding throughout the study.
    4.Presence of gastrointestinal bleeding will be evaluated by digestive endoscopy for patients who have gastrointestinal bleeding externalized before treatment (follow-up endoscopy) and 6 months after starting treatment.
    5.Pharmacokinetics study is carried on by a dosage of bevacizumab before each injection (residual) and 2 hours after the first injection.
    1.Taux d’hémoglobine mesuré avant (M0), à 3 mois et à 6 mois après le début du traitement.
    2.Critères d’efficacité clinique :
    - Evolution de la durée mensuelle des épistaxis et de la fréquence des épisodes à 3 et à 6 mois après l’initiation du traitement. Des grilles d’évaluation des saignements seront complétées par le patient 3 mois avant le début du traitement et pendant toute la durée de l’étude (6 mois).
    - Evolution des scores obtenus au questionnaire de qualité de vie, SF36 et de sévérité des épistaxis (score ESS) complétés à l’inclusion (M0), à la fin du traitement (M3) et à la fin de l’étude (M6).
    3. Tolérance des perfusions répétées de bévacizumab avec l’observation des évènements indésirables à chaque visite.
    4.La présence de saignements digestifs 6 mois après le début du traitement chez les patients qui en avaient avant l’inclusion, critère évaluée par endoscopie digestive (vidéocapsule).
    5.Etude pharmacocinétique grâce au dosage du bévacizumab résiduel avant chaque nouvelle perfusion et deux heures après la première perfusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months, 6 months
    3 mois, 6 mois
    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 Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned20
    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
    LVLS
    LVLP
    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 months30
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    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)
    In case of a non response of a patient, evaluated at the visit at 6 months, investigator could lift the blind on request to the Anti-Poison Center in Lyon. If patient received placebo, a bevacizumab treatment will be propose apart from clinical trial. If patient received bevacizumab an alternative medical care will be implemented.
    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 Decision2017-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-15
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