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    Summary
    EudraCT Number:2020-003348-10
    Sponsor's Protocol Code Number:TAK-755-3002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-30
    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 - PEI
    A.2EudraCT number2020-003348-10
    A.3Full title of the trial
    A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura)
    Eine prospektive, offene, multizentrische Fortsetzungsstudie der Phase
    IIIb mit einem Behandlungsarm zur Sicherheit und Wirksamkeit von TAK-
    755 (rADAMTS-13, auch BAX 930/SHP655 genannt) bei der
    prophylaktischen und Bedarfsbehandlung von Patienten mit schwerer
    kongenitaler thrombotisch-thrombozytopenischer Purpura (cTTP; Upshaw-
    Schulman-Syndrom oder hereditärer thrombotisch-thrombozytopenischer
    Purpura)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655)
    A.4.1Sponsor's protocol code numberTAK-755-3002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04683003
    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 SponsorBaxalta Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxalta Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc.
    B.5.2Functional name of contact pointLaura Flynn
    B.5.3 Address:
    B.5.3.1Street Address650 East Kendall Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02191
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16175833875
    B.5.6E-maillaura.flynn@takeda.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 nameRecombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13
    D.3.2Product code TAK-755 orBAX930 or SHP655
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNApadamtase alfa
    D.3.9.2Current sponsor codeTAK-755 (SHP655 or BAX930)
    D.3.9.3Other descriptive nameRecombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
    D.3.9.4EV Substance CodeSUB195523
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApadamtase alfa
    D.3.9.2Current sponsor codeTAK-755 (BAX930 or SHP655)
    D.3.9.3Other descriptive nameRecombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
    D.3.9.4EV Substance CodeSUB195523
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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: 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 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 nameRecombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13
    D.3.2Product code TAK-755 orBAX930 or SHP655
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNApadamtase alfa
    D.3.9.2Current sponsor codeTAK-755 (SHP655 or BAX930)
    D.3.9.3Other descriptive nameRecombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
    D.3.9.4EV Substance CodeSUB195523
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApadamtase alfa
    D.3.9.2Current sponsor codeTAK-755 (BAX930 or SHP655)
    D.3.9.3Other descriptive nameRecombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs
    D.3.9.4EV Substance CodeSUB195523
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    congenital Thrombotic thrombocytopenic purpura (TTP)
    E.1.1.1Medical condition in easily understood language
    congenital Thrombotic thrombocytopenic purpura
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    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 the long-term safety and tolerability of TAK-755 (rADAMTS-13) in terms of related treatment-emergent adverse events (TEAEs) and related serious adverse events (SAEs) in both the prophylactic and the on-demand cohorts.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy prophylactic TAK-755 treatment for the prevention of acute TTP events.
    2. To evaluate the efficacy of TAK-755 in controlling of acute TTP events.
    3. To evaluate the proportion of subjects that require dose modification and supplemental dose in the prophylactic cohort.
    4. To evaluate the incidence of isolated TTP manifestations in subjects receiving prophylactic treatment.
    For more secondary objectives please refer to the Protocol.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: An open-label, single dose, multicenter exploratory substudy to assess the safety and bioavailability of TAK-755 (rADAMTS13) given by subcutaneous administration in subjects with cTTP receiving prophylactic treatment with TAK-755 in the Phase 3b continuation study (TAK-755-3002)
    Date: 12Apr2022
    Exploratory Objectives:
    1. To evaluate the safety and tolerability of TAK-755 administered subcutaneously in terms of adverse
    events (AEs) and serious adverse events (SAEs).
    2. To assess the bioavailability of TAK-755 administered subcutaneously.
    3. To evaluate the pharmacokinetics (PK) of ADAMTS13 for up to 14 days after subcutaneous (SC) administration.
    E.3Principal inclusion criteria
    Applies to Subjects who have completed the TAK-755 Phase 3 pivotal study (Study 281102) in the prophylactic cohort
    Subjects who have completed TAK-755 Study 281102 (in the prophylactic cohort who meet ALL of the following criteria are eligible for this study:
    1. Subject or legally authorized representative has provided signed informed consent (≥18 years of age) and/or assent form (<18 years of age).
    2. Subject is 0 to 70 years of age at the time of screening of the 281102 study.
    3. Subject has been diagnosed with severe congenital ADAMTS-13 deficiency.
    4. Subject does not display any severe TTP signs (platelet count <100,000/μL and elevation of LDH >2 × upper limit of normal [ULN]) at screening (prophylactic cohort only).
    5. Subjects ≥16 years of age must have a Karnofsky score ≥70% and subjects <16 years of age must have a Lansky score ≥80%.
    6. If female of childbearing potential, subject presents with a negative serum or urine pregnancy test confirmed not more than 7 days before the first IP administration and agrees to employ highly effective birth control measures for the duration of the study and to undergo quarterly pregnancy testing.
    7. Sexually active males must use an accepted and effective method of contraception during the treatment
    and until a minimum of 16 days after the last dose administered.
    8. Subject is willing and able to comply with the requirements of the protocol.
    Applies to naïve subjects and non-naïve on-demand cohort subjects
    Naïve subjects can only be enrolled in this continuation study after enrollment of the adult subjects in the prophylactic arm of the TAK-755 Phase 3 pivotal study (Study 281102) has been completed. Naïve pediatric subjects can be enrolled after enrollment of the respective age cohort into Study 281102 has been completed. The following criteria also applies to subjects who completed study 281101, but did not participate in 281102.
    The following criteria do not apply to subjects from the Expanded Access Program or subjects from 281102 who had an allergic reaction to SoC. See separate criteria below for study eligibility of EAP subjects and subjects from study 281102 who had an allergic reaction to SoC.
    Naïve subjects and subjects who were enrolled into the on-demand cohort of the TAK-755 Phase 3 pivotal study (281102) who meet ALL of the following criteria are eligible for this study:
    1. Subject is naïve or was enrolled into the on-demand cohort of the TAK-755 Study 281102 for treatment of an acute TTP event but did not receive prophylactic treatment.
    2. Subject or legally authorized representative has provided signed informed consent (≥18 years of age) and/or assent form (<18 years of age).
    3. Subject is 0 to 70 years of age at the time of screening.
    4. Subject has been diagnosed with severe congenital ADAMTS-13 deficiency defined as:
    a. Confirmed by molecular genetic testing, documented in subject history or at screening, and
    b. ADAMTS-13 activity <10% as measured by the fluorescence resonance energy transfer (FRETS)-Von Willebrand factor (VWF)73 assay, documented in subject history or at screening. Subjects currently receiving standard of care prophylactic therapy may exceed 10% ADAMTS-13 activity at screening.
    5. Subjects currently receiving prophylactic therapy will be screened immediately prior to their usual prophylactic infusion.
    6. Subject does not display any severe TTP signs (platelet count <100,000/μL and elevation of LDH >2 × ULN) at screening (prophylactic cohort only).
    7. Subjects ≥16 years of age must have a Karnofsky score ≥70% and subjects <16 years of age must have a Lansky score ≥80%.
    8. Subject is hepatitis C virus negative (HCV) as confirmed by antibody or polymerase chain reaction testing OR HCV positive (HCV+) if their disease is chronic but stable.
    9. If female of childbearing potential, subject presents with a negative serum or urine pregnancy test confirmed not more than 7 days before the first IP administration and agrees to employ highly effective birth control measures for the duration of the study and to undergo quarterly pregnancy testing.
    10. Sexually active males must use an accepted and effective method of contraception during treatment and until a minimum of 16 days after the last dose administered.
    11. Subject is willing and able to comply with the requirements of the protocol.
    Subjects from an Expanded Access Program or subjects in Study 281102 who had an allergic reaction to standard of care prophylactic treatment must meet ALL of the following criteria.
    1. Subject or legally authorized representative has provided signed informed consent (≥18 years of age) and/or assent form (<18 years of age), as applicable.
    2. Subject is 0 to 70 years of age at the time of screening.
    For more inclusion criteria please refer to the Protocol.
    E.4Principal exclusion criteria
    The subject will be excluded from the study if any of the following exclusion criteria are met.
    Applies to subjects who have completed TAK-755 Phase 3 pivotal study (Study 281102):
    1. Known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS-13, hamster protein, or other constituents of TAK-755.
    2. Subject has presence of a functional ADAMTS-13 inhibitor at screening.
    3. In the opinion of the investigator, the subject has another clinically significant concomitant disease that may pose additional risks for the subject.
    4. Subject is receiving or anticipates receiving another investigational drug and/or interventional drug within 30 days before enrollment.
    5. Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
    6. Subject suffers from a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude.
    7. Subject is a family member or employee of the sponsor or investigator
    Applies to naïve subjects and non-naïve on-demand cohort subjects:
    The following criteria do not apply to subjects from the Expanded Access Program or subjects from 281102 who had an allergic reaction to SoC. The following criteria also applies to subjects who completed study 281101, but did not participate in 281102.
    1. Subject has been diagnosed with any other TTP-like disorder (microangiopathic hemolytic anemia), including immune-mediated TTP.
    2. Known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS-13, hamster protein, or other constituents of TAK-755.
    3. Subject has presence of a functional ADAMTS-13 inhibitor at screening.
    4. Subject has a medical history of a genetic or acquired immune deficiency that would interfere with the assessment of product immunogenicity, including subjects who are human immunodeficiency virus-positive with an absolute cluster of differentiation 4 (CD4) count <200/mm3 or who are receiving chronic immunosuppressive drugs.
    5. Subject has a history of significant neurological events, such as major stroke, indicating that a relapse might have severe consequences, as judged by the investigator.
    6. Subject has been diagnosed with severe cardiovascular disease (New York Heart Association classes 3 to 4).
    7. Subject with end stage renal disease requiring chronic dialysis.
    8. Subject has been diagnosed with hepatic dysfunction, as evidenced by, but not limited to, any of the following:
    a. Serum alanine aminotransferase ≥2 × ULN
    b. Severe hypoalbuminemia <24 g/L
    c. Portal vein hypertension (e.g., presence of otherwise unexplained splenomegaly, history of esophageal varices).
    9. In the opinion of the investigator, the subject has another clinically significant concomitant disease that may pose additional risks for the subject.
    10. Subject has been treated with an immunomodulatory drug, excluding topical treatment (e.g., ointments, nasal sprays), within 30 days prior to enrollment. Use of corticosteroids in conjunction with administration of fresh frozen plasma to prevent allergic reactions is permitted.
    11. Subject has an acute illness (e.g., influenza, flu-like syndrome, allergic rhinitis/conjunctivitis, bronchial asthma) at the time of screening (prophylactic cohort only).
    12. Subject is receiving or anticipates receiving another investigational drug and/or interventional drug within 30 days before enrollment.
    13. Subject has a history of drug and/or alcohol abuse within the last 2 years.
    14. Subject has a progressive fatal disease and/or life expectancy of ≤3 months.
    15. Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
    16. Subject suffers from a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude.
    17. Subject is a family member or employee of the sponsor or investigator.
    18. If female, subject is pregnant or lactating at the time of enrollment.
    Applies to subjects from an Expanded Access Program or subjects in Study 281102 who had an allergic reaction to standard of care prophylactic treatment:
    1. Subject has been diagnosed with any other TTP-like disorder (microangiopathic hemolytic anemia), including immune-mediated TTP.
    2. Known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS-13, hamster protein, or other constituents of TAK-755.
    3. Subject has presence of a functional ADAMTS-13 inhibitor at screening.
    4. Subject has a medical history of a genetic or acquired immune deficiency that would interfere with the assessment of product immunogenicity, including subjects who are human immunodeficiency virus-positive with an absolute cluster of differentiation 4 (CD4) count <200/mm3 or who are receiving chronic immunosuppressive drugs.
    E.5 End points
    E.5.1Primary end point(s)
    There is no primary efficacy endpoint for this study, as the primary objective of the study is long-term safety.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the study
    E.5.2Secondary end point(s)
    The key secondary efficacy outcome measure is the incidence of acute TTP events among subjects receiving TAK-755 prophylactically. Analyses will be conducted using FAS for the prophylactic cohort. The number and incidence rate of acute TTP events will be summarized by enrollment status (“Naïve” or having completed the Phase 3 pivotal study [Study 281102]) and overall.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Australia
    Brazil
    Canada
    China
    Colombia
    India
    Israel
    Japan
    Korea, Republic of
    Taiwan
    Thailand
    United States
    Austria
    France
    Poland
    Sweden
    Netherlands
    Spain
    Switzerland
    Czechia
    Germany
    Italy
    Belgium
    Denmark
    Hungary
    Norway
    Portugal
    Russian Federation
    Turkey
    Ukraine
    United Kingdom
    Serbia
    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
    last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 77
    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 treatment or use of study drug once it is commercially available.
    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 Decision2022-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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