Funding for this research was provided by:
Horizon 2020 Framework Program of the European Union (667224)
Deutsche Forschungsgemeinschaft and the Open Access Publishing Fund of the University of Tübingen
Received: 21 February 2019
Accepted: 31 May 2019
First Online: 27 June 2019
Ethics approval and consent to participate
: 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; <i>Authority:</i> 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; <i>Authority:</i> 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; <i>Authority:</i> Finnish Medicines Agency (FIMEA) reference no. 44/ 2017 approved conduct.Germany: Ethics: Ethics Committee at the University Hospital Tuebingen, <i>reference no.</i> 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 <i>approved with short oral consent; Authority: Centrale Commissie Mensgebonden Onderzoek (CCMO)</i> 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; <i>Authority:</i> Norwegian Medicines Agency reference no. 17/04729–11 approved conduct.Poland: Ethics: to be submitted <i>Authority:</i> 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; <i>Authority:</i> Swissmedic - Swiss agency for therapeutic products, reference no. 2017DR3135 approved conduct.
: Not applicable.
: Y. Jacobs and R. van der Vlught-Meijer are employees of ACE Pharmaceuticals, the company that holds the Dutch marketing authorization registration for Acepurin® (allopurinol 1 g/100 ml) for intravenous application for treatment of gout. C. van Veldhuizen and B. Laméris are the former owners of ACE Pharmaceuticals. All four contributed to the development of the study protocol. All other contributors declare that they do not have competing interests.