Acquired Hemophilia A
Conditions
Keywords
Drug Therapy
Brief summary
Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. They also have longer bleeding compared to people without AHA. The main aim of the study is to learn how safe OBIZUR is in adults with AHA. Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting. The treatment of the participants will be determined by the treating physicians. During the study, data already existing in the participants' medical record and new data will be collected.
Detailed description
This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.
Interventions
DRUGOBIZUR
OBIZUR injection.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with AHA. * Participants who are determined to have the clinical need to receive Obizur treatment. * Participants aged 18 years or older at time of initiation of Obizur treatment. * Participants agreed to participate in the study and voluntarily signed the informed consent.
Exclusion criteria
* Participants with hypersensitivity to any of the components of this drug. * Participants with Congenital Hemophilia A with Inhibitors (CHAWI). * Participants for whom Obizur treatment is contraindicated as per product label. * Participants who has participated in another 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 during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI) | Up to 3 months | Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment. |
| Number of Participants With Expected/Unexpected AEs and SAEs | Up to 3 months | Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome. |
| Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs | Up to 3 months | An ADR refers to any undesirable and unintended reaction which occurs during or following the administration of the drug, and in which a causal relationship with the drug cannot be ruled out. In the event that a causal relationship with the drug remains unknown amongst reported adverse events, such reaction shall be considered an adverse drug reaction. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome. |
| Number of Participants With Special Situation Report (SSR) | Up to 3 months | SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use"; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; Unintended benefit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Overall Bleeding Control | Up to 3 months | Overall Bleeding Control will be determined as either bleeding stopped or did not stop. |
| Time to Achieve Bleeding Control With OBIZUR Injection | Up to 3 months | Time to achieve bleeding control will be assessed from initiation of OBIZUR Injection (start time) to the time to achieve bleeding control (stop time). |
| Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control | Up to 3 months | Number of OBIZUR injection infusion required to achieve bleeding control will be reported. |
| Dose of OBIZUR Required to Stop the Bleeding | Up to 3 months | OBIZUR dose required to stop the bleeding will be reported. |
| Percentage of Participants With Bleeding Events | Up to 3 months | Bleeding events will be evaluated and reported as re-bleed, concurrent bleed and subsequent bleed. Re-bleed: if it occurs in the same anatomical location and within 72 hours of the resolution of the previous bleeding. Concurrent bleed: if it occurs at the same time (that is, during treatment or within 72 hours of resolution) as previous bleed but at a different anatomical location. Subsequent bleed: if it is a new bleed occurring 72 hours after the resolution of the previous bleed (either in the same anatomical location or in a new one). |
Countries
South Korea
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed