Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment

PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

September 30, 2011

Study Completion Date

November 30, 2013

Conditions
Hemophilia A
Interventions
BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Treated according to the Kogenate FS package insert indications and study physician recommendations

Trial Locations (38)

1756

Sofia

4002

Plovdiv

9010

Varna

10029

New York

10065

New York

11026

Bucharest

15213

Pittsburgh

30322

Atlanta

32801

Orlando

37920

Knoxville

40202

Louisville

44106

Cleveland

46260

Indianapolis

50035

Brasov

53226

Milwaukee

55455

Minneapolis

60611

Chicago

60612

Chicago

64108

Kansas City

72202

Little Rock

77030

Houston

80045

Aurora

84132

Salt Lake City

85724

Tucson

92868

Orange

95817

Sacramento

300011

Timișoara

900591

Constanța

20007-2197

Washington D.C.

52242-1089

Iowa City

02115

Boston

48201-2196

Detroit

89109-2803

Las Vegas

07112

Newark

17033-0850

Hershey

C1221 ADC

Buenos Aires

S2000CKF

Rosario

022328

Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY