ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)
NCT ID: NCT02093741
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65 participants
OBSERVATIONAL
2013-09-20
2016-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ADVATE - 2mL
Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
The investigators shall determine all treatment regimens according to product labeling information and standard practice.
Interventions
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Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
The investigators shall determine all treatment regimens according to product labeling information and standard practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≤12 years of age
* Participant's legally authorized representative(s) has provided written informed consent
* Participant is prescribed ADVATE and will only receive ADVATE reconstituted in 2 mL sterile water for injection (SWFI)
* Documented history of prior exposure to ADVATE
* Documented evidence of negative inhibitor test result during ≤10 EDs prior to study entry
Exclusion Criteria
* Known allergic reaction to mouse or hamster proteins
* Participant has a requirement for a major surgical procedure at the time of enrollment
* Participant has no prior exposure to a FVIII concentrate
* Participant currently being treated with an immune tolerance induction (ITI) regimen
* Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand disease)
* Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device or PASS registry during the course of this study
12 Years
ALL
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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CHRU Pellegrin, Hématologie - CRTH
Bordeaux, , France
Centre Hospitalier Générale, CTH
Chambéry, , France
CRTH Laboratoire d'Hématologie CHRU - Hôpital du Bocage
Dijon, , France
American Memorial Hospital, Service de Pédiatrie
Reims, , France
CHU de Rennes Hôpital Pontchaillou
Rennes, , France
Hôpital Nord, Pédiatrie
Saint-Priest-en-Jarez, , France
CHRU Purpan, CRTH - Pavillon Sénac
Toulouse, , France
CHU de Nancy - Hôpital de Brabois- CRTH - Laboratoire Hémato-Hémostase
Vandœuvre-lès-Nancy, , France
Universitätskliniken des Saarlandes, Klinik für pädiatrische Onkologie und Hämatologie
Homburg, Saarland, Germany
Klinikum Stuttgart, Olgahospital, Pädiatrie 5
Stuttgart, , Germany
Heim Pál Children's Hospital, Department of Oncology
Budapest, , Hungary
Borsod-Abaúj-Zemplén County Hospital, Pediatric Dep
Miskolc, , Hungary
Mohacsi Korhaz, Department of Pediatrics
Mohács, , Hungary
Josa Andras Egyetemi Oktatokorhaz, Department of Pediatrics
Nyíregyháza, , Hungary
Leeds General Infirmary
Leeds, West Yorkshire, United Kingdom
Birmingham Children's Hospital NHS Trust
Birmingham, , United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, , United Kingdom
Countries
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Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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061101
Identifier Type: -
Identifier Source: org_study_id
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