Acquired Hemophilia A
Conditions
Brief summary
The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.
Interventions
BIOLOGICALOBIZUR
Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
Sponsors
Baxalta Innovations GmbH, now part of Shire
Baxalta now part of Shire
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participant (or legal representative) is willing to provide informed consent * Participant is being treated or was treated (treatment initiation within 30 days) with Obizur in routine clinical practice
Exclusion criteria
* Participant has known anaphylactic reactions to the active substance, hamster protein or to any of the following excipients: Polysorbate 80; sodium chloride; calcium chloride dihydrate; sucrose; Tris Base; Tris HCl; Tri-sodium citrate dihydrate; sterilized water for injections * Participant has participated in a clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device at study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of AEs and SAEs including seriousness, severity and outcome | From first administration of Obizur up to 180 days after the last administration of Obizur. | AE - adverse event, SAE - serious adverse event. |
| Number of AESIs including seriousness, severity, relationship to therapy, outcome, and treatment discontinuation | From first administration of Obizur up to 180 days after the last administration of Obizur. | Adverse Events of Special Interest (AESI) are as follows: hypersensitivity reactions, thromboembolic events and dose dispensing medication errors. |
| Number of thromboembolic events | From first administration of Obizur up to 180 days after the last administration of Obizur. | Thromboembolic events include disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction and stroke. |
| Number of dose dispensing medication errors | From first administration of Obizur up to 180 days after the last administration of Obizur. | Dose dispensing medication erros include miscalculation of dose while prescribing (calculation of correct dose based on the participant's weight) or administration of the incorrect dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose per infusion administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur | From first administration of Obizur up to 180 days after the last administration of Obizur. | Bleeding control defined as all bleeding stopped. |
| Immunogenicity; newly recognized anti-pFVIII inhibitor or increase in titre of anti-pFVIII inhibitors and evolution of titre over time | From first administration of Obizur up to 180 days after the last administration of Obizur. | — |
| Time to achieve bleeding control, death or change in haemostatic treatment other than Obizur | From first administration of Obizur up to 180 days after the last administration of Obizur. | Bleeding control defined as all bleeding stopped. |
| Number of infusions administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur | From first administration of Obizur up to 180 days after the last administration of Obizur. | Bleeding control defined as all bleeding stopped. |
| Obizur treatment regimen, as available | From first administration of Obizur up to 180 days after the last administration of Obizur. | This may include details of the Obizur treatment regimen utilized, as available |
| Other medication administered for haemostatic control, as available | From first administration of Obizur up to 180 days after the last administration of Obizur. | This may include additional medications, treatments and procedures (other than Obizur) undertaken to control a bleeding episode. |
| Overall effectiveness assessment for resolution of bleeding | From first administration of Obizur up to 180 days after the last administration of Obizur. | Resolution of bleeding determined as either bleeding stopped or did not stop. If bleeding did not stop, a reason should be provided. |
Countries
Austria, France, Germany, Italy, Netherlands, United Kingdom, United States
Outcome results
None listed