ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)

CompletedOBSERVATIONAL
Enrollment

65

Participants

Timeline

Start Date

September 20, 2013

Primary Completion Date

January 20, 2016

Study Completion Date

January 20, 2016

Conditions
Hemophilia ACongenital Factor VIII (FVIII) Deficiency
Interventions
BIOLOGICAL

Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]

The investigators shall determine all treatment regimens according to product labeling information and standard practice.

Trial Locations (17)

1131

Heim Pál Children's Hospital, Department of Oncology, Budapest

3629

Borsod-Abaúj-Zemplén County Hospital, Pediatric Dep, Miskolc

4400

Josa Andras Egyetemi Oktatokorhaz, Department of Pediatrics, Nyíregyháza

7700

Mohacsi Korhaz, Department of Pediatrics, Mohács

21034

CRTH Laboratoire d'Hématologie CHRU - Hôpital du Bocage, Dijon

31059

CHRU Purpan, CRTH - Pavillon Sénac, Toulouse

33076

CHRU Pellegrin, Hématologie - CRTH, Bordeaux

35033

CHU de Rennes Hôpital Pontchaillou, Rennes

42270

Hôpital Nord, Pédiatrie, Saint-Priest-en-Jarez

51092

American Memorial Hospital, Service de Pédiatrie, Reims

54511

CHU de Nancy - Hôpital de Brabois- CRTH - Laboratoire Hémato-Hémostase, Vandœuvre-lès-Nancy

66421

Universitätskliniken des Saarlandes, Klinik für pädiatrische Onkologie und Hämatologie, Homburg

70176

Klinikum Stuttgart, Olgahospital, Pädiatrie 5, Stuttgart

73011

Centre Hospitalier Générale, CTH, Chambéry

LS1 3EX

Leeds General Infirmary, Leeds

B4 6NH

Birmingham Children's Hospital NHS Trust, Birmingham

WC1N 3JH

Great Ormond Street Hospital for Children NHS Trust, London

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT02093741 - ADVATE 2 mL Post-Authorization Safety Surveillance (PASS) | Biotech Hunter | Biotech Hunter