A Study in Children, Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate

Takeda

Status: Completed

Conditions: Hemophilia A

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT04876365

MACS-2020-061601 (Other Identifier)

TAK-660-4004

Details and patient eligibility

About

The main aims of the study are to assess the safety profile of Adynovate as well as how well people respond to the preventive treatment with Adynovate.

This study is about reviewing and collecting data of the participants before and after the switch to Adynovate that are already available. No new information will be collected during this study. The total time for data collection in the study will be approximately 72 months (36 months before and 36 months after switching to Adynovate). Participants will not receive Adynovate as part of this study.

As participants are not treated in this study, they do not need to visit their doctor in addition to their normal visits.

Enrollment: 153 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with severe hemophilia A.

• All age groups (less than [<] 12 and greater than [>] 12 years of age).

• Participant with greater than equal to (>=) 150 documented exposure days (EDs).

• Treated with Adynovate:

  • Having a PK analysis done/data available for post-hoc modeling
  • Having recorded clinical outcomes analysis: for > 6 months

• Treated with a SHL/EHL-FVIII product for at least six months before switching to Adynovate

• To qualify for the secondary objective participants will need to have a WAPPS study performed on Adynovate and on the SHL/EHL-FVIII they were treated before switching.

Exclusion criteria

• Any participant who meets any of the following criteria will not qualify for entry into the study:
• Participants with only on-demand Factor VIII (FVIII) use.
• Current presence of FVIII inhibitory antibodies. (Participants with a history of inhibitors, if any, will be considered for a sensitivity analysis).
• Diagnosis of other inherited or acquired hemostatic defect other than hemophilia A.

Trial design

153 participants in 1 patient group

All Participants

Description:

All participants diagnosed with severe hemophilia A previous received prophylaxis regimen for Standard Half-life/Extended Half-life Factor VIII (SHL/EHL-FVIII) products will be compared to after the participants switched to regular prophylaxis with Adynovate with at least 6 months follow up.

Treatment:

Other: Non-Interventional