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Clinical trials for Birth Defects

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    38 result(s) found for: Birth Defects. Displaying page 1 of 2.
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    EudraCT Number: 2011-003325-10 Sponsor Protocol Number: 1.01 Start Date*: 2012-08-10
    Sponsor Name:VU University Medical Center
    Full Title: A randomized controlled trail on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth
    Medical condition: congenital anomalies
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10004953 Birth premature LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10007607 Cardiac septal defects congenital HLT
    14.1 10010331 - Congenital, familial and genetic disorders 10041524 Spina bifida PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005552-38 Sponsor Protocol Number: ProFET Start Date*: 2021-01-27
    Sponsor Name:Västragötalandsregionen, Sahlgrenska Universitetssjukhuset
    Full Title: Vaginal progesterone as luteal support for improvement of live birth in frozen/thawed in-vitro fertilization natural cycles; a multicenter, open, randomized trial
    Medical condition: infertility
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000446-30 Sponsor Protocol Number: 02-2014 Start Date*: 2014-07-23
    Sponsor Name:Maasstad Ziekenhuis
    Full Title: Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial. The Medico-GDM trial.
    Medical condition: Pregnant women with a high risk of gestational diabetes mellitus (GDM)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004491-10 Sponsor Protocol Number: CAC-001-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An Open-Label, Single-Center, Nonrandomized Study to Compare the Therapeutic Efficacy of To Be Marketed (TBM) Cholic Acid Capsules with that of the Currently Used (CU) Formulation of Cholic Acid Ca...
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004259-38 Sponsor Protocol Number: CAC-91-10-10 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: Investigation in the Pathogenesis of Liver Disease in Patients with Inborn Errors of bile Acid Metabolism
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2005-001564-31 Sponsor Protocol Number: AMB 222 Start Date*: 2005-10-07
    Sponsor Name:Myogen Inc.
    Full Title: A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    7.0 10037400 low
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002727-38 Sponsor Protocol Number: OMS721-HCT-002 Start Date*: Information not available in EudraCT
    Sponsor Name:Omeros Corporation
    Full Title: A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant...
    Medical condition: Thrombotic microangiopathies following haematopoietic stem cell transplant
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10064477 Coagulopathies and bleeding diatheses (excl thrombocytopenic) HLGT
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    20.0 10005329 - Blood and lymphatic system disorders 10053567 Coagulopathies HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004528-36 Sponsor Protocol Number: CAC-002-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An open-label, single center, non-randomized, continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis.
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2019-000913-35 Sponsor Protocol Number: BECRO/OV/DORZO Start Date*: 2019-05-21
    Sponsor Name:BECRO (Cyprus) Ltd
    Full Title: A Randomized, Observer-blind, two Parallel Group, Multi-center, Clinical Trial for Comparing the Efficacy and Tolerability of Dorzo-Vision® sine Preservative-Free Eye Drops vs. Trusopt® Preservativ...
    Medical condition: Open angle glaucoma or ocular hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10015919 Eye disorders SOC
    20.0 10015919 - Eye disorders 10030348 Open angle glaucoma PT
    20.0 10015919 - Eye disorders 10030043 Ocular hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002924-35 Sponsor Protocol Number: APHP180592 Start Date*: 2021-01-18
    Sponsor Name:ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
    Full Title: Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir
    Medical condition: Step 1: Maternal administration of 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP Step 2: Maternal daily administration of 240 or 480 milligrams of letermovir (1x240 mg-ta...
    Disease:
    Population Age: Children, Under 18, Adults Gender: Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004484-39 Sponsor Protocol Number: BAY1895344/18594 Start Date*: 2017-07-18
    Sponsor Name:Bayer AG
    Full Title: An open-label, first-in-human, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose and / or recommended Phase II dose of the A...
    Medical condition: Part A+A.1: Histologically confirmed solid tumors or NHL Part A J-arm : Advanced solid tumors Part B: a) DDR deficient advanced solid tumors: i) CRPC; ii) HER2- negative BC (estrogen-receptor posit...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028997 Neoplasm malignant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-001245-32 Sponsor Protocol Number: PGX-III-AP-002 Start Date*: 2011-10-19
    Sponsor Name:Forest Laboratories, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
    Medical condition: Coronary Artery Disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001988-52 Sponsor Protocol Number: 90101 Start Date*: 2012-07-30
    Sponsor Name:EORTC
    Full Title: Cross-tumoral Phase 2 clinical trial exploring Crizotinib (PF-02341066) in patients with advanced tumours induced by causal alterations of either ALK or MET.
    Medical condition: Locally advanced and/or metastatic malignant tumor (anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, papillary renal cell carcinoma type 1, alveolar soft part sarcoma, clear cell...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065867 Alveolar rhabdomyosarcoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10002227 Anaplastic large cell lymphoma T- and-cell types PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067918 Inflammatory myofibroblastic tumor LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001882 Alveolar soft part sarcoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067946 Renal cell carcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065865 Clear cell sarcoma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) NL (Completed) FR (Completed) NO (Completed) SI (Prematurely Ended) IT (Completed) PL (Completed) DK (Prematurely Ended) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006188-23 Sponsor Protocol Number: CER-001-CLIN-007 Start Date*: 2012-02-14
    Sponsor Name:Cerenis Therapeutics
    Full Title: CER-001 Infusions in Subjects with Familial HDL-c Deficiency
    Medical condition: Familial HDL-c Deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003418-25 Sponsor Protocol Number: CTU/2014/120 Start Date*: 2016-03-29
    Sponsor Name:MeiraGTx UK II Ltd
    Full Title: An Open-label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno-Associated Virus Vector (AAV2/5-OPTIRPE65) for Gene Therapy of Adults and Children with Retinal Dystrophy associated with D...
    Medical condition: Leber Congenital Amaurosis (LCA) caused by mutations in RPE65
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10070667 Leber's congenital amaurosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-003438-26 Sponsor Protocol Number: 161504 Start Date*: 2017-02-14
    Sponsor Name:Baxalta US Inc.
    Full Title: Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases
    Medical condition: Primary Immunodeficiency Disease (PIDD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) DK (Completed) CZ (Completed) SK (Completed) FR (Completed) GR (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2018-001227-39 Sponsor Protocol Number: 779322 Start Date*: 2019-12-11
    Sponsor Name:University of Bergen, Faculty of Medicin, Department of Clinical Dentistry
    Full Title: A randomized controlled clinical trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in com...
    Medical condition: Patients in need of dental implant(s) in the upper and lower jaws with presence of bone defects with loss in vertical height and < than 4 mm in lateral width
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10005958 Bone disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002856-26 Sponsor Protocol Number: ADO-EP02(ML29328) Start Date*: 2016-12-19
    Sponsor Name:SRH Wald-Klinikum Gera GmbH
    Full Title: A PHASE II, SINGLE-ARMED, MULTICENTER TRIAL OF NEOADJUVANT VISMODEGIB IN PATIENTS WITH LARGE AND/OR RECURRENT RESECTABLE BASAL CELL CARCINOMA
    Medical condition: Patients with large and/or recurrent resectable basal cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004146 Basal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-003501-29 Sponsor Protocol Number: 161503 Start Date*: 2022-12-13
    Sponsor Name:Baxalta Innovations GmbH [...]
    1. Baxalta Innovations GmbH
    2. Baxalta US Inc.
    Full Title: Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects with Primary Immunodeficiency Diseases
    Medical condition: Primary Immunodeficiency Diseases (PID)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-005000-17 Sponsor Protocol Number: JU-BioMiStem-01 Start Date*: 2021-09-20
    Sponsor Name:Jagiellonian University
    Full Title: A Randomized, Double Blind, Two Arms, Controlled Phase I/II Safety and Efficacy Study on MesoCellA-Ortho Tissue Engineered Product Intraarticularly Administrated in Adult Patients with Osteoarthrosis
    Medical condition: articular knee diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
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