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    Summary
    EudraCT Number:2021-002297-11
    Sponsor's Protocol Code Number:NOPRODPAPUH3001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-16
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-002297-11
    A.3Full title of the trial
    A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Providing long-term treatment access in patients with pulmonary hypertension completing a parent study and having no other treatment access alternative
    A.3.2Name or abbreviated title of the trial where available
    PLATYPUS
    A.4.1Sponsor's protocol code numberNOPRODPAPUH3001
    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 SponsorActelion Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 supportActelion Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3171524 2166
    B.5.5Fax number+3171524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 Yes
    D.2.1.1.1Trade name Opsumit
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMacitentan
    D.3.2Product code JNJ-67896062
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMacitentan
    D.3.9.1CAS number 441798-33-0
    D.3.9.2Current sponsor codeJNJ-67896062
    D.3.9.4EV Substance CodeSUB89247
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameFixed dose combination of macitentan and tadalafil (JNJ-68150420)
    D.3.2Product code CJNJ-68150420-ZZZ-G001 (ACT064992D)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMacitentan
    D.3.9.1CAS number 441798-33-0
    D.3.9.2Current sponsor codeJNJ-67896062
    D.3.9.4EV Substance CodeSUB89247
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTadalafil
    D.3.9.1CAS number 171596-29-5
    D.3.9.2Current sponsor codeJNJ-10291697
    D.3.9.4EV Substance CodeSUB12602MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 3
    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 Opsumit
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMacitentan
    D.3.2Product code JNJ-67896062
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMacitentan
    D.3.9.1CAS number 441798-33-0
    D.3.9.2Current sponsor codeJNJ-67896062
    D.3.9.4EV Substance CodeSUB89247
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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 Opsumit
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMacitentan
    D.3.2Product code JNJ-67896062
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMacitentan
    D.3.9.1CAS number 441798-33-0
    D.3.9.2Current sponsor codeJNJ-67896062
    D.3.9.4EV Substance CodeSUB89247
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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
    Pulmonary Hypertension
    E.1.1.1Medical condition in easily understood language
    Pulmonary hypertension (PH) is a disease associated with abnormally high pressure in the blood vessels of the lungs
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10037400
    E.1.2Term Pulmonary hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 of the respective study interventions in treated participants
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial are not applicable

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Macitentan:
    1. Participant must sign an informed consent form (ICF) (or their legally
    acceptable representative must sign) indicating that participant
    understands the purpose of, and procedures required for, the study and
    is willing to participate in the study. In case of enrollment of participants
    below 18 years old, parent(s) (preferably both if available or as per local
    requirements) must sign the ICF. Assent is also required of children
    capable of understanding the nature of the study (typically 7 years of
    age and older) as described in Informed Consent Process
    2.Participant treated with oral macitentan at the end of a sponsor
    parent study and:
    a) The indication of the parent study is included in this ISA (PAH or
    CTEPH for adults, PAH for pediatric participants)
    b) Participant has completed the parent study
    c) No alternative means of access to study intervention (or equivalent
    approved therapy) have been
    identified
    d) Participant may continue to benefit from treatment with the study
    intervention
    e. Pediatric participant is at least 2 years old
    3. A woman of childbearing potential must:
    a. have a negative urine or serum pregnancy test prior to first intake of
    study intervention,
    b. agree to perform monthly urine pregnancy test up to the end of the
    safety follow-up period,
    c. Agree to follow contraceptive methods as defined in this ISA
    (Appendix A.3, Contraceptive and Barrier Guidance) until 30 days after
    the last intake of the study intervention.
    Fixed Dose Combination of macitentan + tadalafil
    1. Participant must sign an informed consent form (ICF) (or their legally
    acceptable representative must sign) indicating that participant
    understands the purpose of, and procedures required for, the study and
    is willing to participate in the study.
    2.Participant treated with FDC of macitentan 10 mg and tadalafil 40 mg
    at the end of a sponsor parent study and:
    a. The indication of the parent study is included in this ISA (ie, PAH)
    b. Participant has completed the parent study
    c. No alternative means of access to study intervention (or equivalent
    approved therapy) have been
    identified
    d. Participant may continue to benefit from treatment with the study
    intervention
    3. A woman of childbearing potential must:
    a. have a negative urine or serum pregnancy test prior to first intake of
    study intervention,
    b. agree to perform monthly urine pregnancy test up to the end of the
    safety follow-up period,
    c. Agree to follow contraceptive methods as defined in this ISA
    (Appendix C.3, Contraceptive and Barrier Guidance) until 30 days after
    the last intake of the study intervention
    E.4Principal exclusion criteria
    General exclusion criteria
    1. Participants prematurely discontinued the study intervention in their
    parent study (participant's or investigator's decision).
    2. Female participant being pregnant, or breastfeeding, or planning to
    become pregnant while enrolled in this study.
    3. Planned or current treatment with another investigational treatment.
    Macitentan exclusion criteria
    1. Known allergies, hypersensitivity, or intolerance to macitentan or its
    excipients (refer to the macitentan IB).
    2. Hemoglobin <80 g/l.
    3. Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3 ×(ULN) .
    4. Known and documented severe hepatic impairment ie, Child-Pugh
    Class C. For participants with hepatic impairment, Child-Pugh Class
    should be fully assessed and documented in the source documents at
    Screening.
    5. Treatment with a strong cytochrome P450 (CYP)3A4 inhibitor (eg,
    ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin,
    nefazodone, ritonavir, and saquinavir).
    6. Systemic Treatment with a moderate dual CYP3A4/CYP2C9 inhibitor (eg,
    fluconazole, amiodarone) or uses a co-administration of a combination of
    moderate CYP3A4 (eg ciprofloxacin, cyclosporine, diltiazem,
    erythromycin, verapamil) and moderate CYP2C9 inhibitors (eg,
    miconazole, piperine). If a participant coming from a parent
    study is currently under such a concomitant treatment, the participant
    may be enrolled as per the investigator's discretion based on his/her
    clinical judgement and risk-benefit assessment.
    7. Systemic Treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin,
    rifampicin, rifapentin, carbamazepine, phenobarbital, phenytoin, St.
    John's Wort) within 1 month prior to baseline.
    8. Interruption of study intervention for more than 4 weeks since the
    last dose of study intervention taken in the parent study.
    9. Treatment with an ERA (other than the study intervention).
    Macitentan and Tadalafil exclusion criteria:
    1. Known allergies, hypersensitivity, or intolerance to macitentan or
    tadalafil or their excipients
    2. Hemoglobin
    3. Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3 ×
    (ULN) range.
    4. Known and documented severe hepatic impairment ie, Child-Pugh
    Class C.
    5. Severe renal impairment (estimated glomerular filtration rate (eGFR)/creatinine clearance
    6. Loss of vision in one or both eyes because of non-arteritic anterior ischemic optic
    neuropathy, regardless of whether or not this episode was in connection with
    phosphodiesterase type 5 inhibitor treatment (tadalafil).
    7. Systemic treatment with a strong CYP3A4 inhibitor (eg, ketoconazole,
    itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir,
    and saquinavir).
    8. Systemic treatment with a moderate dual CYP3A4/CYP2C9 inhibitor (eg,
    fluconazole, amiodarone) or uses a co-administration of a combination of moderate
    CYP3A4 (eg ciprofloxacin, cyclosporine, diltiazem, erythromycin, verapamil) and
    moderate CYP2C9 inhibitors (eg, miconazole, piperine). If a participant coming
    from a parent study is currently under such a concomitant treatment, the participant
    may be enrolled as per the investigator's discretion based on his/her clinical
    judgment and risk-benefit assessment.
    9. Treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin, rifampicin,
    rifapentin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) within 1 month
    prior to baseline.
    10. Treatment with doxazosin
    11. Treatment with any form of organic nitrate, either regularly or intermittently.
    12. Treatment with an ERA, phosphodiesterase type 5 inhibitor, or soluble guanylate
    cyclase stimulator.
    13. Interruption of study intervention for more than 4 weeks since the last dose of study
    intervention taken in the parent study.
    14. Clinically significant aortic or mitral valve disease; pericardial constriction; restrictive
    or congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias;
    significant left ventricular dysfunction; or left ventricular outflow obstruction, as per
    the investigator’s opinion
    15. Known permanent atrial fibrillation, as per the investigator's opinion
    16. Documented pulmonary veno-occlusive disease (PVOD)
    17. Any known factor or disease that may interfere with the participant’s safety per the
    investigator’s judgment
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of treatment-emergent adverse events (AEs), treatment-emergent AEs leading to discontinuation, serious adverse events
    (SAEs), and/or deaths
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline until End-of-Study (EOS)
    E.5.2Secondary end point(s)
    Secondary endpoints not applicable.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints not applicable.
    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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Platform 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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Ukraine
    Taiwan
    Belarus
    China
    India
    Korea, Republic of
    Russian Federation
    South Africa
    Belgium
    Bulgaria
    France
    Poland
    Romania
    Türkiye
    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 End of Study is considered as the last scheduled study End of Trial or safety follow-up (EOS) visit, whichever comes last for the last participant in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    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 Yes
    F.1.1Number of subjects for this age range: 80
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    W przypadku zgłoszenia uczestników poniżej 18 roku życia, rodzic(e) musi(szą) podpisać ICF. Zgoda jest również wymagana od dzieci zdolnych do
    zrozumienie charakteru badania (zwykle 7 lat i starsze) zgodnie z opisem w Procesie Świadomej Zgody.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 123
    F.4.2.2In the whole clinical trial 390
    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
    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 Decision2022-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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