Updates are available Correction dated 2024-03-15
Click to view Correction: https://doi.org/10.1186/s13063-024-08031-x
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Authors
Engel, Corinna http://orcid.org/0000-0002-8565-6986
Rüdiger, Mario
Benders, Manon J. N. L.
van Bel, Frank
Allegaert, Karel
Naulaers, Gunnar
Bassler, Dirk
Klebermaß-Schrehof, Katrin
Vento, Maximo
Vilan, Ana
Falck, Mari
Mauro, Isabella
Metsäranta, Marjo
Vanhatalo, Sampsa
Mazela, Jan
Metsvaht, Tuuli
van der Vlught, Roselinda
Franz, Axel R.
,
Poets, Christian F.
Guimarães, Hercilia
Stiri, Tom
Cattarossi, Luigi
van Veldhuizen, Cees K. W.
Maiwald, Christian A.
Bergmann, Iris
Weiss, Monika
Eichhorn, Andreas
Raubuch, Michael
Schuler, Birgit
Laméris, Bas
van Ramshorst, Thirza
Kliniken, Tirol
Brandner, Johannes
Tackoen, Marie
Reibel, Ruth
Ilmoja, Mari-Liis
Saik, Pille
Käär, Ruth
Andresson, Pille
der J. W. Goethe, Klinikum
Schloesser, Main Rolf
Carus, Carl Gustav
Winkler, Stefan
Hoehn, Thomas
Teig, Norbert
Schroth, Michael
Fusch, Christoph
Thome, Ulrich H.
Ehrhardt, Harald
Carnielli, Ancona Virgilio
Napolitano, Marcello
Faldini, Francesca
“V.Buzzi”, Bambini
Lista, Milano Gianluca
Barbarini, Mario
Pagani, Laura
Mastretta, Emmanuele
Vento, Giovanni
Fumagalli, Monica
van Weissenbruch, Mirjam M.
van Straaten, Henrica L. M.
Annink, Kim V.
Dudink, Jeroen
Derks, Jan B.
de Boer, Inge P.
Meijssen, Clemens B.
de Haan, Timo R.
van Rooij, Linda G.
van Hillegersberg, Jacqueline L.
van Dongen, Minouche
Dijkman, Koen P.
van Houten, Marlies A.
van der Schoor, Sophie R. D.
Schneider, Moritz
Nestaas, Eirik
Nakstad, Britt
Karpinski, Lukas
Gulczynska, Ewa
Ferraz, Claudia
Pereira, Almerinda
Barroso, Rosalina
da Graça, Mendes
Tomé, Teresa
Pinto, Filomena
Rodilla, Juan Martínez
Pico, Maria Luz.Couce
Suazo, José Antonio Hurtado
Valverde, Eva
Lorenzo, José Ramón Fernández
Boix, Héctor
Parrilla, Francisco Jimenez
Blanco, Dorotea
Loureiro, Begoña
Moral-Pumarega, Maria Teresa
Maletzki, Julia
Knoepfli, Claudia
Hagmann, Cornelia
Kleber, Michael
Stocker, Martin
Riedel, Thomas
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Funding
Funding for this research was provided by:
Horizon 2020 Framework Programme (667224)
Universitätsklinikum Tübingen
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Article History
Received: 31 October 2023
Accepted: 22 November 2023
First Online: 24 January 2024
Change Date: 15 March 2024
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s13063-024-08031-x
Declarations
:
: The ALBINO trial is performed in accordance with the Declaration of Helsinki and the guidelines of Good Clinical Practice (GCP). Written informed consent must be obtained by the parents or legal guardians before full participation in the study (i.e., before administration of the second dose of study medication (if indicated) and before data entry into the database). Whether oral consent by at least one parent is obtained following short information or an approved waiver of consent is applied before administration of the first dose of study medication, depends on the approvals of the responsible national ethics committees (as detailed elsewhere). At the time of publication, the ALBINO trial is currently taking place in 10 European countries and may expand to other countries, including Poland and Portugal, once ethical approval has been obtained.Austria: Ethics: Ethikkommission Medizinische Universität Wien, reference no. 1731/2017, approved with deferred consent; Authority: Bundesamt für Sicherheit im Gesundheitswesen, reference no. 10680185 approved conduct. Belgium: Coordinating ethical committee: Ethical Committee UZ Leuven reference no. S60224, approved with deferred consent; Authority: Federal Agency for Medicines and Health Products Brussels, reference no. FAGG/ R&D/MMN approved conduct. Estonia: Ethics: Research Ethics Committee of the University of Tartu (UT REC), reference no. 272/T-13, approved with deferred consent; Authority: State Agency of Medicines clinical trial, reference no. 17–044 approved conduct. Finland: Ethics: Naisten, lasten ja psykiatrian eettinen toimikunta, Helsingin ja Uudenmaan sairaanhoitopiiri reference no. HUS/1528/2017 approved with deferred consent; Authority: Finnish Medicines Agency (FIMEA) reference no. 44/ 2017 approved conduct. Germany: Ethics: Ethics Committee at the University Hospital Tuebingen, reference no. 703/2016AMG1, approved with short oral consent; Authority: Bundesinstitut für Arzneimittel und Medizinprodukte, reference no. 4041912 approved conduct. Italy: Ethics: COMITATO ETICO UNICO REGIONALE sede operative CENTRO di RIFERIMENTO ONCOLOGICO reference no. 6.1 21/11/2017 - ID 2167 approved with short oral consent; Authority: AIFA- Agenzia Italiana del Farmaco reference no. 97707 approved conduct. Netherlands: Ethics: The ethical committee of the University Medical Center Utrecht reference no. NL57237.041.16 approved with short oral consent; Authority: Centrale Commissie Mensgebonden Onderzoek (CCMO) reference no. NL57237.041.16 approved conduct. Norway: Ethics: REK — Regionale komiteer for medisinsk og helsefaglig forskningsetikk reference no. 2017/800 approved with deferred consent; Authority: Norwegian Medicines Agency reference no. 17/04729–11 approved conduct. Poland: Ethics: to be submitted Authority: to be submitted. Portugal: Ethics: CEIC - Comissão de Ética para a Investigação Clínica - Waiting for approval; Authority: INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. — approved conduct. Spain: Ethics: Ethics Committee for Research with Medications at the Hospital Universitario y Politécnico de La Fe. reference no. 2016–000222-19 approved with Short Oral Consent; Authority: Spanish Agency of Medicines reference no.2016–000222-19 approved with Short Oral Consent. Switzerland: Ethics: Kantonale Ethikkommission Zürich, reference no. 2017/00961, approved with short oral consent; Authority: Swissmedic — Swiss agency for therapeutic products, reference no. 2017DR3135 approved conduct.
: Not applicable
: R. van der Vlught-Meijer is an employee of ACE Pharmaceuticals, the company that holds the Dutch marketing authorization registration for Acepurin® (allopurinol 1 g/100 ml) for intravenous application for the treatment of gout. C. van Veldhuizen and B. Laméris are the former owners of ACE Pharmaceuticals. All three contributed to the development of the study protocol and therefore the statistical analysis plan. All other contributors declare that they do not have competing interests.
