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
44335
clinical trials with a EudraCT protocol, of which
7366
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 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV...
Medical condition: Adenovirus (AdV), BK virus (BKV), John Cunningham virus (JCV), human herpesvirus 6 (HHV- 6), Epstein-Barr virus (EBV), and cytomegalovirus (CMV) infections and/or disease in patients at high risk f...
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10021881 - Infections and infestations
10060931
Adenovirus infection
PT
20.1
10021881 - Infections and infestations
10055181
BK virus infection
PT
22.0
10021881 - Infections and infestations
10020431
Human herpesvirus 6 infection
PT
21.1
10021881 - Infections and infestations
10015108
Epstein-Barr virus infection
PT
20.1
10021881 - Infections and infestations
10011831
Cytomegalovirus infection
PT
21.1
10021881 - Infections and infestations
10023163
JC virus infection
PT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly
Full Title: Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel (ALVR105)
Medical condition: Adenovirus (AdV), BK virus (BKV), John Cunningham virus (JCV), human herpesvirus 6 (HHV- 6), Epstein-Barr virus (EBV), and cytomegalovirus
(CMV) infections and/or disease in patients at high risk f...
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10021881 - Infections and infestations
10060931
Adenovirus infection
PT
20.1
10021881 - Infections and infestations
10055181
BK virus infection
PT
22.0
10021881 - Infections and infestations
10020431
Human herpesvirus 6 infection
PT
21.1
10021881 - Infections and infestations
10015108
Epstein-Barr virus infection
PT
20.1
10021881 - Infections and infestations
10011831
Cytomegalovirus infection
PT
21.1
10021881 - Infections and infestations
10023163
JC virus infection
PT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly
Full Title: Polyomavirus BK nephropathy after renal transplantation: Randomized clinical trial to demonstrate that switching to mTOR inhibitor is more effective than a reduction of immunosuppressive therapy
Medical condition: Polyoma BK-virus nephropathy is a viral complication after renal transplantation attacking up to 10% of renal transplants and causing transplant failure in 45% of cases. No virustatic treatment exi...
Sponsor Name:Les Hôpitaux Universitaires de Strasbourg
Full Title: Multicenter randomized two arms study evaluating the efficacy of prophylactic Rituximab in adult EBV negative kidney transplant recipients on incidence of EBV primary infection and post-transplant ...
Medical condition: Kidney transplantation
Epstein Barr virus
Full Title: A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Ce...
Medical condition: Prevention of immune mediated allograft rejection in patients with end-stage renal disease (ESRD) who are tissue typed as HLA-A*02 negative and have received a kidney transplant from an HLA-A*02 po...
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
100000004865
10050436
Prophylaxis against renal transplant rejection
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)NL(Trial now transitioned)DE(Completed)BE(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2008-003241-89
Sponsor Protocol Number: LCP-Tacro 3002
Start Date*: 2010-11-05
Sponsor Name:LifeCycle Pharma A/S
Full Title: A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro™ Tablets, Once Daily, Compared to Prograf® Capsules, Twice Daily, in Combi...
Medical condition: Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT