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    EudraCT Number:2019-002669-37
    Sponsor's Protocol Code Number:GB002-2101
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-07
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2019-002669-37
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
    A.4.1Sponsor's protocol code numberGB002-2101
    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 SponsorGB002, Inc.
    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 supportGB002, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGB002, Inc.
    B.5.2Functional name of contact pointClinical Trials Information Website
    B.5.3 Address:
    B.5.3.1Street Address3013 Science Park Road, Suite 200
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2158
    D.3 Description of the IMP
    D.3.1Product nameGB002 Capsules
    D.3.2Product code GB002
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNSeralutinib
    D.3.9.1CAS number 1619931-27-9
    D.3.9.2Current sponsor codeGB002
    D.3.9.3Other descriptive name(S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
    D.3.9.4EV Substance CodeSUB195876
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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 placeboInhalation powder, hard capsule
    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
    Pulmonary Arterial Hypertension (PAH)
    E.1.1.1Medical condition in easily understood language
    WHO Group 1 pulmonary arterial hypertension is associated with raised blood pressure in the pulmonary artery due to abnormalities in the small branches of the pulmonary artery, the arterioles.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077739
    E.1.2Term Pulmonary arterial hypertension WHO functional class I
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the effect of GB002 on improving pulmonary hemodynamics in subjects with WHO Group 1 PAH who are WHO FC II and III.
    E.2.2Secondary objectives of the trial
    Determine the effect of GB002 on improving exercise capacity in this population.

    Evaluate the safety of GB002 in this population.

    • Evaluate the effect of GB002 on right heart function measures in this population
    • Evaluate the effect of GB002 on other measures of efficacy
    • Evaluate the safety of GB002 on other measures of tolerability
    • Evaluate the pharmacokinetics (PK) of GB002
    • Evaluate the pharmacodynamics (PD) of GB002 in this population
    • Heart Rate Expenditure during Six Minute Walk Test (6MWT) – Substudy at select participating sites
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    • Heart Rate Expenditure during 6MWT – Substudy at select participating sites.

    Change from Baseline in heart rate expenditure as measured by continuous heart rate monitoring during the 6MWT.
    E.3Principal inclusion criteria
    1. Adult female subjects aged 18 to 80 years, inclusive, or adult male subjects aged 50 to 80 years, inclusive, at the time of signing the ICF prior to initiation of any study specific activities/procedures.

    2. A current diagnosis of symptomatic PAH classified by one of the following:
    a. Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).
    b. PAH associated with one of the following connective tissue diseases (CTDs):
    − Systemic sclerosis,
    − Mixed CTD or overlap syndrome,
    − Systemic lupus erythematosus.
    c. PAH associated with anorexigen or methamphetamine use.
    d. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
    3. 6MWD ≥ 150 meters and ≤ 550 meters at screening. The lower of 2 consecutive distances should be within 15% of the higher distance.
    4. WHO FC II or III symptomatology.
    5. Treatment with standard of care PAH background therapies. Medications should remain stable for the past 4 weeks prior to consent and throughout screening period.
    Exception: As needed (PRN) diuretics for intermittent weight gain and/or edema are allowed and will be considered a stable dose for this study.
    6. Documentation of cardiac catheterization within the screening period consistent with the diagnosis of PAH and meeting all following criteria, to be confirmed by a central hemodynamic core laboratory:
    a. mPAP ≥ 25 mmHg (at rest);
    b. Pulmonary capillary wedge pressure ≤ 15 mmHg, or mean left atrial pressure (mLAP) or left ventricular-end diastolic pressure (LVEDP) ≤ 15 mmHg in the absence of left atrial obstruction;
    c. PVR ≥ 400 dyne•s/cm5.
    7. Pulmonary function tests (PFTs) and diffusing capacity of the lungs for carbon monoxide (DLCO) at screening with following criteria met:
    a. Forced expiratory volume in 1 second (FEV1) ≥60% (predicted);
    b. DLCO ≥40% predicted except for subjects with PAH associated with systemic sclerosis (SSc-APAH) where DLCO ≥30% is required.
    If the subject uses continuous oxygen therapy, they must be able to complete PFTs without oxygen. Subjects who are unable to complete PFTs without oxygen therapy are not eligible for the study.

    Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    8. Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin[hCG]) at screening and a negative urine pregnancy test on Day 1 before first administration of IP. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required and results must be negative.
    9. Women of nonchildbearing potential: Evidence of post-menopausal status. Women will be considered post-menopausal if ave been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
    − Women <50 years of age would be considered post-menopausal if have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
    − Women ≥50 years of age would be considered post-menopausal if have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
    10. Women of childbearing potential who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception (defined in Appendix 4 in Section 10.4 of the protocol) from consent through 30 days following the last administration of IP; acceptable methods include hormonal contraception (oral contraceptives – as long as on stable dose, patch, implant, or injection), intrauterine devices, or other form of highly effective contraception.
    11. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP. Male subjects should refrain from sperm donation throughout this period, except for the purpose of fertility analysis as part of this protocol.

    12. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    The subject must be excluded from participating in the study if he/she meets any of the following:
    Medical Conditions
    1.Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by ventilation-perfusion(V/Q)scan, computed tomography (CT)-angiogram, or pulmonary angiogram prior to screening.If not available previously, then test should be performed during the screening period.
    2.Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure>160 mm Hg or sitting diastolic blood pressure>100 mm Hg during screening visit after a period of rest
    3.Systolic blood pressure<90 mm Hg during screening and baseline visits
    Other Exclusion Criteria
    4.WHO Pulmonary Hypertension Group 2–5
    5.HIV- associated PAH
    6.History of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
    a. Aortic or mitral valve disease(stenosis or regurgitation) defined as greater than mild aortic insufficiency, mild aortic stenosis (AS), mild mitral stenosis(MS),moderate mitral regurgitation(MR)
    b. Mechanical cardiac valve requiring anticoagulation
    c. Pericardial constriction or pericardial effusion with tamponade physiology
    d. Restrictive cardiomyopathy
    e. Left ventricular ejection fraction(LVEF)≤50% by ECHO within 12 weeks prior to screening
    Note:If ECHO images are not adequate to provide an accurate estimate of LVEF then a multigated acquisition(MUGA)or cardiac magnetic resonance imaging (cMRI)scan or single photon emission computed tomography(SPECT) imaging can be used to obtain an accurate LVEF
    f. Documented symptomatic coronary disease (ie angina or previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft),previous or planned coronary artery bypass surgery)
    7. Untreated obstructive sleep apnea
    8. History of atrial septostomy within 180 days prior to screening
    9. Pulmonary venous occlusive disease(PVOD)
    10. Moderate-to-severe hepatic impairment classified as Child-Pugh Class B or C at screening
    11. History of malignancy within 5 years prior to screening,with the exception of localized non-metastatic basal cell carcinoma of the skin and in-situ carcinoma of the cervix
    12. History of a potentially life-threatening cardiac arrhythmia with an ongoing risk
    13. Active and/or uncontrolled bacterial,viral,or fungal infections which require systemic therapy
    14. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg. history of intracranial hemorrhage)
    15. Any musculoskeletal disease or any other disease that limits evaluation of 6MWT
    16.Pregnant or nursing or intends to become pregnant during the duration of the study
    17.Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who,in the opinion of the investigator,may experience severe symptoms following the ingestion of lactose
    Diagnostic Assessments
    18.Body weight<40 kg at screening
    19.Chronic renal insufficiency as defined by an estimated glomerular filtration rate (eGFR)≤30 mL/min via CKD-epi at screening or requires dialytic therapy or hemofiltration
    20.Hemoglobin (Hgb) concentration<8.5g/dL at screening
    21.Evidence of active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C, or tuberculosis(TB) infections.
    Prior Therapy
    22.Inhaled prostanoids;these drugs must be withdrawn prior to or at screening
    23.Use of anticoagulants(ie coumadin or novel oral anticoagulants[NOAC]) at randomization; if on coumadin or a NOAC, these drugs can be withdrawn,if clinically appropriate, during the screening period, and subjects should have normal coagulation parameters prior to the randomization (see Section 10.6 for examples of prohibited anticoagulants)
    24.Requirement of intravenous(IV)inotropes (ie levosimendan, dopamine, dobutamine, milrinone, norepinephrine)other than an IV prostanoid within 4 weeks of screening
    Prior/Concurrent Clinical Study Experience
    25.Prior participation in GB002 studies and/or prior treatment with GB002
    26.Currently participating in or has participated in a study of an investigational agent or has used an investigational device for the treatment of PAH within 4 weeks prior to screening
    Note: Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks or at least 5 half-lives (whichever is greater after the last dose of the previous investigational agent
    Other Exclusion Criteria
    27.Current use of inhaled tobacco
    28.A positive test for drugs of abuse (amphetamines,methamphetamines,cocaine,phencyclidine[PCP]). Retest may be performed for potential false positive results.Certain drugs may be allowed if prescribed for medical conditions(i.e opioids for pain,benzodiazepines for anxiety) and approved by the medical monitor.Ingestible or topical marijuana is allowed
    E.5 End points
    E.5.1Primary end point(s)
    Determine the effect of GB002 on improving pulmonary hemodynamics in subjects with WHO Group 1 PAH who are WHO FC II and III:
    • Change in Pulmonary Vascular Resistance (PVR) using Right Heart Catheterization (RHC)

    RHC will be done to assess the severity of hemodynamic impairment and to subsequently help to identify risk status of subjects with a diagnosis of PAH. These data will also be used to evaluate the efficacy of GB002.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    E.5.2Secondary end point(s)
    Determine the effect of GB002 on improving pulmonary hemodynamics in subjects with WHO Group 1 PAH who are WHO FC II and III:
    • Change in distance achieved on the six-minute walk test (6MWT), (Δ6MWD) from Baseline to Week 24.

    Evaluate the safety of GB002 in this population:
    • Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs (SAEs), and treatment-emergent adverse event of special interests (AESIs).

    Evaluate the effect of GB002 on right heart function measures in this population:
    • Change from Baseline in tricuspid annular peak systolic velocity (TAS’), right ventricular (RV) Tei index and right ventricular free wall strain (RVFWS) by echocardiogram (ECHO).

    Evaluate the effect of GB002 on other measures of efficacy:
    • Change from Baseline in European QOL – 5 dimensions – 5 levels (EQ-5D-5L).
    • Change from Baseline in WHO FC.
    • Time to clinical worsening (TTCW) defined as any of the following:
    − death by any cause
    − non-elective hospitalization for PAH, including atrial septostomy;
    − reduction from Baseline in the 6MWD by ≥ 15%;
    − worsening WHO FC;
    − signs or symptoms of right-sided heart failure.
    • Change from Baseline in pulmonary right atrial pressure (RAP), cardiac output (CO), cardiac index (CI), stroke volume (SV), and mean pulmonary arterial pressure (mPAP).

    Evaluate the safety of GB002 on other measures of tolerability:
    • Change from Baseline in clinical laboratory parameters, ECG parameters, pulmonary function and vital signs.

    Evaluate the PK of GB002:
    • Plasma concentrations of GB002 and its metabolites, if appropriate.

    Evaluate the pharmacodynamics (PD) of GB002 in this population:
    • Change from Baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP)
    • Changes from Baseline in biomarkers measured in blood samples, circulating cells, mucosal fluid samples.

    Heart Rate Expenditure during 6MWT – Substudy at select participating sites:
    • Change from Baseline in heart rate expenditure as measured by continuous heart rate monitoring during the 6MWT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoint:
    Baseline to Week 24
    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 No
    E.6.10Pharmacogenetic Yes
    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. 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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 67
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 38
    F.4.2.2In the whole clinical trial 80
    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)
    The Investigator should resume standard of care treatment, including treatment with appropriate medications, as deemed necessary.
    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 Decision2020-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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