The European Paediatric Network for Haemophilia Management ( PedNet Registry)

NCT02979119 | Recruiting

• 1 other identifier: Version 6.4 November 2022
• Study Type: observational
• Target: 4,000
• Locations: 19 countries
• Sites: 39

Brief Summary

Rationale: Haemophilia is a rare disease; to improve knowledge international collaboration is needed. Well-defined clinical data will be collected from complete cohorts in order to prevent selection bias. Objective: To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.

Conditions

Factor VIII Deficiency; Factor IX Deficiency

Keywords

Hemophilia; Children; Inhibitors; Prophylaxis; Long-term outcome; Congenital

Outcome Measures

Primary Outcomes (1)

• Number of patients with antibody development to exogenous clotting factors

  Allo-antibodies against Factor VIII and IX; Blood test: measurement in Bethesda units (BU), positive according to local standards, for most labs \>0.5 BU

  Until patient reaches age of 18

Secondary Outcomes (2)

• Long term outcome of haemophilia on joint status using the Hemophilia Joint Health Score (HJHS) and MRI techniques.

  From diagnose every 5 years until patient reaches age of 18

• Long term outcome different Immune Tolerance Induction (ITI) therapies in patients with inhibitor.

  From date first positive inhibitor titer preferably every 3 years until patient reaches age of 18

Study Arms (4)

Cohort I

Children with mild ( FVIII/IX 6 to 25%), moderate (FVIII/IX 1 to 5%) or severe (FVIII/IX \<1%) haemophilia A or B, born from January 1st 2000 until December 31st 2009 who have been or are to be treated with coagulation proteins in one of the participating centres

Cohort II

Children with mild ( FVIII/IX 6 to 25%), moderate (FVIII/IX 1 to 5%) or severe (FVIII/IX \<1%) haemophilia A or B, born from January 1st 2010 until December 31st 2019 who have been or are to be treated with coagulation proteins in one of the participating centres

Cohort III

Children with mild ( FVIII/IX 6 to 25%), moderate (FVIII/IX 1 to 5%) or severe (FVIII/IX \<1%) haemophilia A or B, born from January 1st 2020 until December 31st 2029 who have been or are to be treated with coagulation proteins in one of the participating centres

Cohort IV

Cohort IV Group/Cohort Description: Children with mild ( FVIII/IX 6 to 25%), moderate (FVIII/IX 1 to 5%) or severe (FVIII/IX \<1%) haemophilia A or B, born from January 1st 2030 until December 31st 2039 who have been or are to be treated with coagulation proteins in one of the participating centres

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children with mild ( FVIII/IX 6 to 25%), moderate (FVIII/IX 1 to 5%) or severe (FVIII/IX \<1%) haemophilia A or B, born from January 1st 2000 until January 1st 2030 who have been or are to be treated in one of the participating centres

You may qualify if:

• Diagnosed with Haemophilia A or B
• Factor VIII/ IX activity of \<1 to 25%
• Complete records of Factor treatment and bleeds
• Treated in one of the participating centres

You may not qualify if:

• Patients referred because of an inhibitor\*
• Informed consent not obtained

Sponsors & Collaborators

• PedNet Haemophilia Research Foundation: lead

Study Sites (39)

Universitäts-Klinik für Kinder- und Jugendheilkunde

Graz, A-8036, Austria

COMPLETED

Medical University of Vienna - Department of Paediatrics

Vienna, Austria

RECRUITING

Service of Pediatric Haematology University Hospital Leuven

Leuven, B-3000, Belgium

RECRUITING

Division of Hematology/Oncology Hôpital St Justine

Montreal, H3T 1C5, Canada

RECRUITING

Division of Haematology/Oncology Hospital for Sick Children

Toronto, M5G-1X8, Canada

RECRUITING

Haemophilia Comprehensive Care Centre, Centre for Thrombosis and Haemostasis Children's University Hospital Brno

Brno, 613 00, Czechia

RECRUITING

Department of Paediatric Haematology/oncology - University Hospital Motol

Prague, 150 06, Czechia

RECRUITING

Department of Pediatrics Århus Kommunehospital Skejby Sygehus

Aarhus, DK-8200, Denmark

RECRUITING

Children's Hospital Helsinki University Hospital

Helsinki, FIN-00029, Finland

RECRUITING

Service Hématologique Centre Regional Traitement d'Hemophilie Bicetre

Le Kremlin-Bicêtre, F-94270, France

RECRUITING

Service d'Hématologie Pédiatrique Hôpital Universitaire La Timone

Marseille Cedex-05, F-13385, France

RECRUITING

Centre de traitement des hémophiles Hôpital Universitaire Purpan

Toulouse, F-31052, France

RECRUITING

Charité Campus Virchow Klinikum, Klinik für Pädiatrie m.S. Onkologie und Hämatologie

Berlin, Germany

RECRUITING

Department of Internal Medicine, Hemophilia Treatment Center, Vivantes Klinikum im Friedrichshain

Berlin, Germany

RECRUITING

Institut für Experimentelle Hämatologie und Transfusionsmedizin Universitätsklinikum Bonn

Bonn, D-53127, Germany

RECRUITING

Klinik Bremen-Mitte Prof.-Hess-Kinderklinik

Bremen, D 28177, Germany

RECRUITING

Hämophilie Zentrum Rhein Main

Frankfurt, D-60596, Germany

RECRUITING

University Hospital Frankfurt & Goethe University - Clinical and Molecular Hemostasis, Department of Pediatrics

Frankfurt am Main, Germany

RECRUITING

Dr. v. Haunersches Kinderspital University of Munich

Munich, D-80337, Germany

RECRUITING

Haemophilia-Haemostasis Unit St. Sophia Children's Hospital

Athens, GR-11527, Greece

RECRUITING

Children's Health Ireland (CHI) at Crumlin

Dublin, Ireland

RECRUITING

The National Hemophilia Center Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

RECRUITING

Gaslini Hospital

Genova, I-16184, Italy

RECRUITING

A. Bianchi Bonomi Hemophilia and Thrombosis Centre IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

COMPLETED

Van Creveld Kliniek University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

RECRUITING

Oslo University Hospital

Oslo, Norway

NOT YET RECRUITING

Centro Hospitalar São João, S. Imuno-hemoterapia

Porto, Portugal

RECRUITING

Unitat Hemofilia Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Unidad de Coagulopatías Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital General Unidad de Hemofilia 1 Sur Hospitales Universitarios Virgen del Rocio

Seville, 41013, Spain

COMPLETED

Unidad de Coagulopatias Congenitas Hospital Universitario la Fe

Valencia, 46009, Spain

RECRUITING

Lund University Hospital

Malmo, S-20502, Sweden

RECRUITING

Department of Pediatrics, Clinic of Coag. Disorders Karolinska Hospital

Stockholm, S-17176, Sweden

RECRUITING

Inselspital Bern, University Children's Hospital

Bern, Switzerland

RECRUITING

Birmingham Children's Hospital NHS Trust - Department of Haematology

Birmingham, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Edinburgh, EH9 1LF, United Kingdom

COMPLETED

Department of Haematology Royal Hospital for Sick Children

Glasgow, G 3885, United Kingdom

RECRUITING

Haemophila Center Great Ormond Street Hospital for Children

London, WC1N3JH, United Kingdom

COMPLETED

Related Publications (33)

• de Kovel M, van Haaster AC, Carcao M, Ranta S, Glosli H, Rivard GE, Kenet G, Kurnik K, Van Geet C, Carvalho M, Andersson NG, Kartal-Kaess M, Ljung R, van den Berg HM; PedNet Study Group. Blood Group O Does Not Increase the Risk of Inhibitors in Severe Haemophilia A: Data from the PedNet Study Group. Haemophilia. 2025 May;31(3):419-423. doi: 10.1111/hae.70035. Epub 2025 Mar 23.

  PMID: 40123267 BACKGROUND

• Carcao M, Konigs C, Andersson NG, de Kovel M, de Boer-Verdonk E, Motwani J, Blatny J, Olivieri M, van den Berg M, Fischer K. Predictors of immune tolerance induction success in 231 children with severe hemophilia A with high-titer inhibitors - lessons learned from the PedNet prospective cohort study. J Thromb Haemost. 2025 Oct;23(10):3134-3147. doi: 10.1016/j.jtha.2025.07.010. Epub 2025 Jul 22.

  PMID: 40706963 BACKGROUND

• Mendoza A, Rivas I, Hidalgo OB, Cid AR, Olivieri M, Ranta S, Labarque V, Andersson NG, de Kovel M, Alvarez-Roman MT. Impact of Family History of Haemophilia on Diagnosis, Management and Outcomes in Severe Haemophilia. Haemophilia. 2025 Jul;31(4):679-686. doi: 10.1111/hae.70018. Epub 2025 May 30.

  PMID: 40444652 BACKGROUND

• Ranta S, Zapotocka E, Andersson NG, Fischer K, Kenet G, de Kovel M, Konigs C, Labarque V, Male C, Olivieri M, Motwani J. A survey on clinical practice in monitoring and management of bleeding in children with haemophilia A on emicizumab prophylaxis in the PedNet centres. Thromb Res. 2025 May;249:109307. doi: 10.1016/j.thromres.2025.109307. Epub 2025 Mar 19. No abstract available.

  PMID: 40120320 BACKGROUND

• van den Berg HM, Gouw SC, van der Bom JG. Factor VIII products and inhibitors in severe hemophilia A. N Engl J Med. 2013 Apr 11;368(15):1457. doi: 10.1056/NEJMc1301995. No abstract available.

  PMID: 23574131 BACKGROUND

• Gouw SC, van den Berg HM, Fischer K, Auerswald G, Carcao M, Chalmers E, Chambost H, Kurnik K, Liesner R, Petrini P, Platokouki H, Altisent C, Oldenburg J, Nolan B, Garrido RP, Mancuso ME, Rafowicz A, Williams M, Clausen N, Middelburg RA, Ljung R, van der Bom JG; PedNet and Research of Determinants of INhibitor development (RODIN) Study Group. Intensity of factor VIII treatment and inhibitor development in children with severe hemophilia A: the RODIN study. Blood. 2013 May 16;121(20):4046-55. doi: 10.1182/blood-2012-09-457036. Epub 2013 Apr 3.

  PMID: 23553768 BACKGROUND

• Carcao MD, van den Berg HM, Ljung R, Mancuso ME; PedNet and the Rodin Study Group. Correlation between phenotype and genotype in a large unselected cohort of children with severe hemophilia A. Blood. 2013 May 9;121(19):3946-52, S1. doi: 10.1182/blood-2012-11-469403. Epub 2013 Mar 12.

  PMID: 23482934 BACKGROUND

• Clausen N, Petrini P, Claeyssens-Donadel S, Gouw SC, Liesner R; PedNet and Research of Determinants of Inhibitor development (RODIN) Study Group. Similar bleeding phenotype in young children with haemophilia A or B: a cohort study. Haemophilia. 2014 Nov;20(6):747-55. doi: 10.1111/hae.12470. Epub 2014 Jun 3.

  PMID: 24893572 BACKGROUND

• Fischer K, Ljung R, Platokouki H, Liesner R, Claeyssens S, Smink E, van den Berg HM. Prospective observational cohort studies for studying rare diseases: the European PedNet Haemophilia Registry. Haemophilia. 2014 Jul;20(4):e280-6. doi: 10.1111/hae.12448. Epub 2014 May 2.

  PMID: 24784937 BACKGROUND

• Gouw SC, van der Bom JG, Ljung R, Escuriola C, Cid AR, Claeyssens-Donadel S, van Geet C, Kenet G, Makipernaa A, Molinari AC, Muntean W, Kobelt R, Rivard G, Santagostino E, Thomas A, van den Berg HM; PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med. 2013 Jan 17;368(3):231-9. doi: 10.1056/NEJMoa1208024.

  PMID: 23323899 BACKGROUND

• Andersson NG, Auerswald G, Barnes C, Carcao M, Dunn AL, Fijnvandraat K, Hoffmann M, Kavakli K, Kenet G, Kobelt R, Kurnik K, Liesner R, Makipernaa A, Manco-Johnson MJ, Mancuso ME, Molinari AC, Nolan B, Perez Garrido R, Petrini P, Platokouki HE, Shapiro AD, Wu R, Ljung R. Intracranial haemorrhage in children and adolescents with severe haemophilia A or B - the impact of prophylactic treatment. Br J Haematol. 2017 Oct;179(2):298-307. doi: 10.1111/bjh.14844. Epub 2017 Jul 12.

  PMID: 28699675 BACKGROUND

• Mancuso ME, Fischer K, Santagostino E, Oldenburg J, Platokouki H, Konigs C, Escuriola-Ettingshausen C, Rivard GE, Cid AR, Carcao M, Ljung R, Petrini P, Altisent C, Kenet G, Liesner R, Kurnik K, Auerswald G, Chambost H, Makipernaa A, Molinari AC, Williams M, van den Berg HM; European Pediatric Network for Haemophilia Management (PedNet) the REMAIN (REal life MAnagement of children with INhibitors) Study Group. Risk Factors for the Progression from Low to High Titres in 260 Children with Severe Haemophilia A and Newly Developed Inhibitors. Thromb Haemost. 2017 Dec;117(12):2274-2282. doi: 10.1160/TH17-01-0059. Epub 2017 Dec 6.

  PMID: 29212115 BACKGROUND

• Andersson NG, Chalmers EA, Kenet G, Ljung R, Makipernaa A, Chambost H; PedNet Haemophilia Research Foundation. Mode of delivery in hemophilia: vaginal delivery and Cesarean section carry similar risks for intracranial hemorrhages and other major bleeds. Haematologica. 2019 Oct;104(10):2100-2106. doi: 10.3324/haematol.2018.209619. Epub 2019 Feb 21.

  PMID: 30792204 BACKGROUND

• van den Berg HM, Fischer K, Carcao M, Chambost H, Kenet G, Kurnik K, Konigs C, Male C, Santagostino E, Ljung R; PedNet Study Group. Timing of inhibitor development in more than 1000 previously untreated patients with severe hemophilia A. Blood. 2019 Jul 18;134(3):317-320. doi: 10.1182/blood.2019000658. Epub 2019 Jun 11. No abstract available.

  PMID: 31186271 BACKGROUND

• Male C, Andersson NG, Rafowicz A, Liesner R, Kurnik K, Fischer K, Platokouki H, Santagostino E, Chambost H, Nolan B, Konigs C, Kenet G, Ljung R, Van den Berg M. Inhibitor incidence in an unselected cohort of previously untreated patients with severe haemophilia B: a PedNet study. Haematologica. 2021 Jan 1;106(1):123-129. doi: 10.3324/haematol.2019.239160.

  PMID: 31919092 BACKGROUND

• van den Berg HM, Mancuso ME, Konigs C, D'Oiron R, Platokouki H, Mikkelsen TS, Motwani J, Nolan B, Santagostino E; European Pediatric Network for Haemophilia Management (PedNet). ITI Treatment is not First-Choice Treatment in Children with Hemophilia A and Low-Responding Inhibitors: Evidence from a PedNet Study. Thromb Haemost. 2020 Aug;120(8):1166-1172. doi: 10.1055/s-0040-1713097. Epub 2020 Jun 22.

  PMID: 32572865 BACKGROUND

• Andersson NG, Wu R, Carcao M, Claeyssens-Donadel S, Kobelt R, Liesner R, Makipernaa A, Ranta S, Ljung R; ICH study group. Long-term follow-up of neonatal intracranial haemorrhage in children with severe haemophilia. Br J Haematol. 2020 Jul;190(2):e101-e104. doi: 10.1111/bjh.16740. Epub 2020 Jun 9. No abstract available.

  PMID: 32519345 BACKGROUND

• Platokouki H, Fischer K, Gouw SC, Rafowicz A, Carcao M, Kenet G, Liesner R, Kurnik K, Rivard GE, van den Berg HM. Vaccinations are not associated with inhibitor development in boys with severe haemophilia A. Haemophilia. 2018 Mar;24(2):283-290. doi: 10.1111/hae.13387. Epub 2017 Dec 15.

  PMID: 29243367 BACKGROUND

• Khair K, Ranta S, Thomas A, Lindvall K; PedNet study group. The impact of clinical practice on the outcome of central venous access devices in children with haemophilia. Haemophilia. 2017 Jul;23(4):e276-e281. doi: 10.1111/hae.13241. Epub 2017 May 24.

  PMID: 28544163 BACKGROUND

• Hashemi SM, Fischer K, Moons KGM, van den Berg HM; PedNet Study group. Validation of the prediction model for inhibitor development in PUPs with severe haemophilia A. Haemophilia. 2016 Mar;22(2):e116-e118. doi: 10.1111/hae.12895. Epub 2016 Feb 8. No abstract available.

  PMID: 26856685 BACKGROUND

• Ranta S, Motwani J, Blatny J, Buhrlen M, Carcao M, Chambost H, Escuriola C, Fischer K, Kartal-Kaess M, de Kovel M, Kenet G, Male C, Nolan B, d'Oiron R, Olivieri M, Zapotocka E, Andersson NG, Konigs C. Dilemmas on emicizumab in children with haemophilia A: A survey of strategies from PedNet centres. Haemophilia. 2023 Sep;29(5):1291-1298. doi: 10.1111/hae.14847. Epub 2023 Aug 30.

  PMID: 37647211 BACKGROUND

• Labarque V, Mancuso ME, Kartal-Kaess M, Ljung R, Mikkelsen TS, Andersson NG. F8/F9 variants in the population-based PedNet Registry cohort compared with locus-specific genetic databases of the European Association for Haemophilia and Allied Disorders and the Centers for Disease Control and Prevention Hemophilia A or Hemophilia B Mutation Project. Res Pract Thromb Haemost. 2023 Jan 10;7(1):100036. doi: 10.1016/j.rpth.2023.100036. eCollection 2023 Jan.

  PMID: 36798899 BACKGROUND

• Fischer K, Carcao M, Male C, Ranta S, Pergantou H, Kenet G, Kartal-Kaess M, Konigs C, Carvalho M, Alvarez MT, Brakenhoff T, Chambost H, van den Berg HM. Different inhibitor incidence for individual factor VIII concentrates in 1076 previously untreated patients with severe hemophilia A: data from the PedNet cohort. J Thromb Haemost. 2023 Mar;21(3):700-703. doi: 10.1016/j.jtha.2022.11.020. Epub 2022 Dec 22. No abstract available.

  PMID: 36696215 BACKGROUND

• Ljung R, de Kovel M, van den Berg HM; PedNet study group. Primary prophylaxis in children with severe haemophilia A and B-Implementation over the last 20 years as illustrated in real-world data in the PedNet cohorts. Haemophilia. 2023 Mar;29(2):498-504. doi: 10.1111/hae.14729. Epub 2022 Dec 26.

  PMID: 36571801 BACKGROUND

• Schmidt DE, Michalopoulou A, Fischer K, Motwani J, Andersson NG, Pergantou H, Ranta S; PedNet Study Group. Long-term joint outcomes in adolescents with moderate or severe haemophilia A. Haemophilia. 2022 Nov;28(6):1054-1061. doi: 10.1111/hae.14636. Epub 2022 Aug 4.

  PMID: 35925557 BACKGROUND

• Alvarez-Roman MT, Kurnik K; PedNet Study Group. Care for children with haemophilia during COVID-19: Data of the PedNet study group. Haemophilia. 2021 Jul;27(4):e537-e539. doi: 10.1111/hae.14286. Epub 2021 Mar 8. No abstract available.

  PMID: 33683753 BACKGROUND

• Minna K, Anne M, Beatrice N, Rainer K, Susanna R. Correction of haemostasis can be reduced to four days for CVAD implantation in severe haemophilia A patients: Data from the PedNet study group. Haemophilia. 2021 May;27(3):392-397. doi: 10.1111/hae.14231. Epub 2021 Mar 21.

  PMID: 33745218 BACKGROUND

• Andersson NG, Labarque V, Letelier A, Mancuso ME, Buhrlen M, Fischer K, Kartal-Kaess M, Koskenvuo M, Mikkelsen T, Ljung R; PedNet study group. Novel F8 and F9 gene variants from the PedNet hemophilia registry classified according to ACMG/AMP guidelines. Hum Mutat. 2020 Dec;41(12):2058-2072. doi: 10.1002/humu.24117. Epub 2020 Oct 14.

  PMID: 32935414 BACKGROUND

• Jonker CJ, Oude Rengerink K, Hoes AW, Mol PGM, van den Berg HM. Inhibitor development in previously untreated patients with severe haemophilia: A comparison of included patients and outcomes between a clinical study and a registry-based study. Haemophilia. 2020 Sep;26(5):809-816. doi: 10.1111/hae.14100. Epub 2020 Jul 6.

  PMID: 32627880 BACKGROUND

• Andersson NG, Labarque V, Kartal-Kaess M, Pinto F, Mikkelsen TS, Ljung R, Group PS. Factor VIII genotype and the risk of developing high-responding or low-responding inhibitors in severe hemophilia A: data from the PedNet Hemophilia Cohort of 1,202 children. Haematologica. 2024 Apr 1;109(4):1293-1296. doi: 10.3324/haematol.2023.284095. No abstract available.

  PMID: 37881836 BACKGROUND

• Fischer K, Kenet G, Kurnik K, Carcao M, Oldenburg J, Stamm-Mikkelsen T, Cid Haro AR, Koskenvuo M, Blatny J, Konigs C. Determinants of bleeding before and during immune tolerance in 222 boys with severe hemophilia A and inhibitors >5 BU. Blood Adv. 2024 Jan 23;8(2):369-377. doi: 10.1182/bloodadvances.2023011442.

  PMID: 38214949 BACKGROUND

• van der Zwet K, de Kovel M, Motwani J, van Geet C, Nolan B, Glosli H, Escuriola Ettingshausen C, Konigs C, Kenet G, Fischer K; PedNet Investigators. Bleeding control improves after switching to emicizumab: Real-world experience of 177 children in the PedNet registry. Haemophilia. 2024 May;30(3):685-692. doi: 10.1111/hae.15015. Epub 2024 Apr 5.

  PMID: 38578720 BACKGROUND

• de Kovel MS, Escuriola-Ettingshausen C, Konigs C, Ranta S, Fischer K; PedNet Study Group. Bleeding phenotype according to factor level in 825 children with nonsevere hemophilia: data from the PedNet cohort. J Thromb Haemost. 2024 Sep;22(9):2460-2469. doi: 10.1016/j.jtha.2024.05.030. Epub 2024 Jun 10.

  PMID: 38866249 BACKGROUND

Related Links

• Website of the PedNet Registry

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Gili Kenet, PhD, MD

  The National Hemophilia Center Ministry of Health Sheba Medical Center Ramat Gan, Israel

  STUDY DIRECTOR

• Christoph Male, MD

  Medical University of Vienna

  STUDY CHAIR

• Gili Kenet, PhD, MD

  The National Hemophilia Center Ministry of Health Sheba Medical Center Ramat Gan, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelique Hermeling

CONTACT

+31850299993; a.hermeling@pednet.eu

Hermeling

CONTACT

info@pednet.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: December 1, 2016
• Study Start: June 1, 2014
• Primary Completion (Estimated): December 1, 2039
• Study Completion (Estimated): December 1, 2039
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); DK (1); IL (1); IT (3); CA (2); FI (1); DE (7); NL (1); IE (1); FR (3); AU (2); PT (1); SE (2); GB (4); CH (1); CZ (2); NO (1); GR (1); BE (1)