Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Hemophilia A
Interventions
BIOLOGICAL

Xyntha

Xyntha for on-demand treatment of bleeding episodes were according to investigator prescription during the 6 months observation period. The recovery assessed by determining the Factor VIII (FVIII) concentration (FVIII:C) levels in individual subjects at the initial and final visits. The dose of Xyntha for recovery assessments is: single 50 IU/kg (±5 IU/kg) IV bolus infusion. All Xyntha administrations occurred in the clinic (hospital).

Trial Locations (6)

100730

Pfizer Investigational Site, Beijing

200025

Pfizer Investigational Site, Shanghai

215006

Pfizer Investigational Site, Suzhou

300020

Pfizer Investigational Site, Heping District

310003

Pfizer Investigational Site, Hangzhou

510515

Pfizer Investigational Site, Guangzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY