NCT04876365

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

Real-World Effectiveness of PEGylated, Recombinant Antihemophilic Factor (Adynovate) Prophylaxis in Patients With Hemophilia A in Canada: A Retrospective, Intra-patient Comparison With a Before-After Design

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
OTHER	Non-Interventional	This is a Non-Interventional Study.

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-05-06
• Last updated: 2023-07-24

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study