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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-004825-34
    Sponsor's Protocol Code Number:KHB-1801
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-07-19
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2017-004825-34
    A.3Full title of the trial
    A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age related Macular Degeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, double-blinded, randomized, different doses study to evaluate the efficacy and safety of Conbercept injection in patients with Neovascular Age related Macular Degeneration
    A.4.1Sponsor's protocol code numberKHB-1801
    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 SponsorChengdu Kanghong Biotechnology Co., Ltd.
    B.1.3.4CountryChina
    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 supportChengdu Kanghong Biotechnology Co., Ltd.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChengdu Kanghong Biotechnology Co., Ltd.
    B.5.2Functional name of contact pointYan Cheng
    B.5.3 Address:
    B.5.3.1Street Address108 Shuxi Road, Jinniu District
    B.5.3.2Town/ cityChengdu
    B.5.3.3Post code610036
    B.5.3.4CountryChina
    B.5.4Telephone number001610 547 0099
    B.5.6E-mailchengyan@cnkh.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 Lumitin
    D.2.1.1.2Name of the Marketing Authorisation holderChengdu Kanghong Biotechnology Co., Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationChina
    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 nameConbercept 0.5mg (10mg/ml)
    D.3.2Product code KH916, formerly KH902
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNConbercept
    D.3.9.1CAS number 1227158-72-6
    D.3.9.2Current sponsor codeKH916 (formerly KH902)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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 RoleComparator
    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 Eylea®
    D.2.1.1.2Name of the Marketing Authorisation holderBayer plc
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAflibercept
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    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 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 Lumitin
    D.2.1.1.2Name of the Marketing Authorisation holderChengdu Kanghong Biotechnology Co., Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationChina
    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 nameConbercept 1.0mg (20mg/ml)
    D.3.2Product code KH916, formerly KH902
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNConbercept
    D.3.9.1CAS number 1227158-72-6
    D.3.9.2Current sponsor codeKH916 (formerly KH902)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    Neovascular Age Related Macular Degeneration
    E.1.1.1Medical condition in easily understood language
    Wet Age Related Macular Degeneration
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this clinical study is to evaluate the efficacy and safety of 0.5 mg and 1.0 mg conbercept IVT injection compared with the vascular endothelial growth factor (VEGF) antagonist active control, aflibercept IVT injection (2.0 mg, Eylea®, Regeneron Pharmaceuticals, Inc.), in subjects with neovascular age-related macular degeneration (AMD).
    The primary objective is to determine if 0.5 mg or 1.0 mg conbercept is non-inferior to aflibercept 2.0 mg as measured by the change from baseline in best corrected visual acuity (BCVA) by Early Treatment of Diabetic Retinopathy Study (ETDRS) method at the Week 36 visit.
    The primary endpoint is the mean change from baseline in ETDRS BCVA letter score at Week 36 in the study eye.
    E.2.2Secondary objectives of the trial
    1.To evaluate the difference in efficacy between conbercept doses and aflibercept, with respect to the following:
    •Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36;
    •Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36;
    •Mean change from baseline in central retinal thickness (µm) by SD-OCT at Week 36;
    •Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48;
    •Mean change from baseline in ETDRS BCVA letter score at Week 96
    2.To compare the safety and tolerability of conbercept doses and aflibercept, and to evaluate the pharmacokinetics and immunogenicity of conbercept doses, when feasible
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - PK and Immunogenicity study
    - Specular Microscopy
    - Angiography by Optical Coherence Tomography (OCT-A)
    E.3Principal inclusion criteria
    1.Men and women ≥ 50 years of age at the Screening visit;

    2.Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the Screening visit;

    Women of childbearing potential must agree to use a highly effective method of contraception throughout the study (See complete list in the Study Procedures Manual);

    3.Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;

    4.Have active subfoveal CNV lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal FA leakage, or definite subfoveal fluid by SD-OCT in the study eye at Screening;

    5.Have CNV that is at least 50% of total lesion size in the study eye at Screening;

    6.Have a ETDRS BCVA letter score of 78 to 25 (approximately 20/32 to 20/320 equivalent) in the study eye at Screening;

    7.Have ocular media (lens, cornea, vitreous) of adequate clarity to permit high quality fundus imaging;

    8.Are willing and able to sign the study written informed consent form (ICF).
    E.4Principal exclusion criteria
    1.Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins;
    2.Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
    3.Have a total lesion size greater than twelve disc areas (30.5 mm2), including blood, fibrosis and neovascularization, as assessed by FA in the study eye at Screening;
    4.Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is one or more disc areas in size (greater than 2.5 mm2) in the study eye at Screening;
    5.Have scarring or fibrosis making up greater than 50% of total lesion in the study eye at Screening; and/or scarring, fibrosis or atrophy involving the center of the fovea in the study eye at Screening;
    6.Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
    7.Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;
    8.Have any other cause of CNV, including pathologic myopia (defined per protocol as spherical equivalent of -8 diopters or more), ocular histoplasmosis syndrome, angioid streaks, inherited macular dystrophies, choroidal rupture, uveitis, punctate inner choroidopathy, or multifocal choroiditis in the study eye at Screening;
    9.Have a history of or clinical evidence of significant diabetic retinopathy that could impact assessment of vision or affect central vision, diabetic macular edema, or any other vascular disease other than AMD including history or clinical evidence of retinal vein occlusion affecting the study eye at Screening;
    10.Have had prior pars plana vitrectomy in the study eye;
    11.Have presence of a full thickness macular hole at Screening or upon examination at Baseline or a history of a full thickness macular hole in the study eye;
    12.Have a history of intraocular or periocular surgery within three months of Baseline in the study eye, except in the case of lid surgery, which may not have taken place within one month of Baseline as long as it is unlikely to interfere with IVT injection;
    13.Have prior trabeculectomy or other filtration surgery in the study eye;
    14.Have uncontrolled glaucoma (defined as intraocular pressure (IOP) greater than or equal to 22 mmHg at Baseline despite treatment with more than two anti-glaucoma medications) in the study eye;
    15.Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye;
    16.Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the two weeks prior to Screening in either eye;
    17.Have presence or history of scleromalacia in either eye;
    18.Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye;
    19.Have had previous therapeutic radiation in the region of the study eye;
    20.Have history of corneal transplant or presence of a corneal dystrophy that interferes with IOP measurements or imaging in the study eye;
    21.Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period;
    22.Have any concurrent ocular condition in the study eye that, in the opinion of the Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or that otherwise may interfere with the injection procedure or with evaluation of efficacy or safety during the study;
    23.Have any evidence by medical history, physical examination or clinical laboratory testing at Screening or Baseline that shows reasonable suspicion of a disease or condition that contraindicates the use of study medication (conbercept or aflibercept) or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications;
    24.Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline;
    25.Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography;
    26.Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control;
    27.If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to determine if 0.5 mg or 1.0 mg conbercept is non-inferior to aflibercept 2.0 mg as measured by the change from baseline in best corrected visual acuity (BCVA) by Early Treatment of
    Diabetic Retinopathy Study (ETDRS) method at the Week 36 visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint is the mean change in ETDRS BCVA letter score from baseline at Week 36.
    E.5.2Secondary end point(s)
    1.To evaluate the difference in efficacy between conbercept doses and aflibercept, with respect to the following:
    •Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA
    letters) from baseline to Week 36;
    •Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36;
    •Mean change from baseline in central retinal thickness (μm) by SD-OCT at Week 36;
    •Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48;
    •Mean change from baseline in ETDRS BCVA letter score at Week 96
    2. To compare the safety and tolerability of conbercept doses and aflibercept, and to evaluate the pharmacokinetics and immunogenicity of conbercept doses, when feasible
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated at Week 36, Week 48 and Week 96, respectively
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sham
    Aflibercept
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Germany
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Peru
    Philippines
    Poland
    Portugal
    Singapore
    Spain
    Switzerland
    Taiwan
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 467
    F.4.2.2In the whole clinical trial 1140
    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)
    Subjects go back to their standard care.
    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 Decision2018-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-05-19
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