NCT05707351

A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A

A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleeding in Chinese Previously Treated Patients With Severe Hemophilia A (FVIII <1%)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically. Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Adynovate	Adynovate was injected intravenously using an appropriately sized syringe as a bolus infusion over a period of less than or equal to (\<=) 5 minutes (maximum infusion rate, 10 milliliters per minute \[mL/min\]).

Timeline

• Start date: 2023-03-27
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2023-01-31
• Last updated: 2025-05-01
• Results posted: 2025-05-01

Locations

12 sites across 1 country: China