Who is sponsoring NCT02492984?

NCT02492984 is sponsored by Pfizer.

What condition does NCT02492984 study?

NCT02492984 studies Hemophilia A.

What drugs are being tested in NCT02492984?

Interventions: Intravenous infusions of Xyntha.

What is the status of NCT02492984?

NCT02492984 is currently COMPLETED.

Last reviewed 2017-02-16 · How we verify

An Open-label, Single-arm, Post- Authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Xyntha (Moroctocog-alfa (Af-cc), Recombinant Fviii) In Subjects With Hemophilia A In Usual Care Settings In China

NCT02492984 Phase 4 COMPLETED Results posted

An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia A in usual care settings in China for approximately 6 months or or approximately 50 exposure days whichever occurs first

Details

Lead sponsor	Pfizer
Phase	Phase 4
Status	COMPLETED
Enrolment	85
Start date	2015-04
Completion	2016-08

Conditions

Hemophilia A

Interventions

Intravenous infusions of Xyntha

Primary outcomes

Percentage of Participants With Factor VIII (FVIII) Inhibitors — From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).
Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).

Countries

China