A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Hemophilia A
Interventions
BIOLOGICAL

rFVIII (BAY81-8973) on demand

Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization

BIOLOGICAL

rFVIII (BAY81-8973) prophylaxis low-dose

Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.

BIOLOGICAL

rFVIII (BAY81-8973) prophylaxis high-dose

Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.

Trial Locations (47)

2193

Johannesburg

10400

Bangkok

10430

Jakarta

10700

Bangkok

11000

Belgrade

11217

Taipei

18000

Niš

21000

Novi Sad

34000

Kragujevac

40447

Taichung

44280

Guadalajara

45404

Dayton

77030

Houston

77520

Olomouc

78200

San Luis Potosí City

79044

Lviv

95023

Simferopol

100730

Beijing

191186

Saint Petersburg

200025

Shanghai

215006

Suzhou

300011

Timișoara

300020

Tianjin

430031

Baia Mare

500034

Hyderabad

510515

Guangzhou

620149

Yekaterinburg

656050

Barnaul

680009

Khabarovsk

C1221ADC

Buenos Aires

W3410AVV

Corrientes

S2000CKF

Rosario

Unknown

Bogotá

Bucaramanga

Kiev

734-8551

Hiroshima

663-8501

Nishinomiya

634-8522

Kashihara

160-0023

Shinjuku-ku

167-0035

Suginami

011026

Bucharest

022328

Bucharest

851 07

Bratislava

0001

Pretoria

01330

Adana

07059

Antalya

35-100

Izmir

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY