NCT04060836

Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.

Randomized, Open-label, Double Cycle, Crossover, Pharmacokinetics Study of Recombinant Coagulation Factor VIII Injection Versus Xyntha® in Subjects With Hemophilia A.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the study will enter the Prophylactic Therapy Study.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Xyntha	Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.
DRUG	Recombinant Coagulation Factor VIII Injection	A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.

Timeline

• Start date: 2019-05-08
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2019-08-19
• Last updated: 2019-08-19

Locations

5 sites across 1 country: China