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
44339
clinical trials with a EudraCT protocol, of which
7369
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 ).
Full Title: Phase II study to evaluate the clinical potential of 68GaNOTA-Anti-MMR-VHH2 for in vivo imaging of MMR-expressing Macrophages by means of Positron Emission Tomography (PET) in oncological lesions, ...
Medical condition: C1: malignancies of the head and neck.
C2: malignancy with a solid component
C3: carotid plaque, planned for (SOC) carotid endarterectomy.
C4: biopsy-proven Hodgkin or non-Hodgkin lymphoma.
C5: su...
Full Title: An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life...
Medical condition: Primary Hemophagocytic Lymphohistiocytosis (pHLH)
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10021428 - Immune system disorders
10071583
Haemophagocytic lymphohistiocytosis
PT
Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:DE(Completed)ES(Completed)GB(GB - no longer in EU/EEA)IT(Completed)SE(Prematurely Ended)
Full Title: A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (An...
Medical condition: Haemophagocytic lymphohistiocytosis
Disease:
Version
SOC Term
Classification Code
Term
Level
19.0
10010331 - Congenital, familial and genetic disorders
10010331
Congenital, familial and genetic disorders
SOC
Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults
Full Title: A Phase 1b, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Adults and Adolescents with Secondary Hemophagocytic Lymph...
Medical condition: sHLH is a rare and life-threatening inflammatory syndrome characterized by dysregulated immune function. The disease is associated with a massive systemic inflammatory response for which patients r...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10021428 - Immune system disorders
10021428
Immune system disorders
SOC
21.1
10018065 - General disorders and administration site conditions
Full Title: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases
Medical condition: • EBV+ primary imunodeficiency lymphoproliferative disease (LPD)
• EBV+ LPD in the setting of acquired (non-congenital) immunodeficiency
• EBV+ post-transplant LPD involving the central nervous ...
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly
Gender: Male, Female
Trial protocol:FR(Trial now transitioned)AT(Trial now transitioned)BE(Trial now transitioned)IT(Trial now transitioned)ES(Ongoing)
Trial results:(No results available)
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT