BAY81-8973 Pediatric Safety and Efficacy Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

June 9, 2011

Primary Completion Date

September 9, 2019

Study Completion Date

October 27, 2020

Conditions
Haemophilia A
Interventions
BIOLOGICAL

Recombinant Factor VIII (Kovaltry, BAY81-8973)

Main study: 25-50 IU/kg at least 2x/week for 6 months and at least 50 EDs, IV infusion; Extension study: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study), IV infusion. Exposure day (ED): An ED is a unit of time (1 day) in which replacement treatment of Hemophilia is given to a patient.

BIOLOGICAL

Recombinant Factor VIII (Kovaltry, BAY81-8973)

Main study: 15-50 IU/kg at least 1x/week for at least 50 EDs or until inhibitor development, IV infusion; Extension study: For participants having reached at least 50 EDs in main study - Part B: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study), IV infusion. For participants who developed an inhibitor in main study - Part B: up to 200 IU/kg per day or 100 IU/kg twice a day at the discretion of the investigator and coordinating investigator until successful eradication of the inhibitor, or until failure, for up to18 months (treatment beyond 18 months required an agreement with the sponsor and coordinating investigator), IV infusion

Trial Locations (43)

12

Crumlin

1089

Budapest

4002

Plovdiv

4032

Debrecen

7700

Mohács

8200

Århus N

8950

Esplugues de Llobregat

9010

Varna

10003

Cáceres

15006

A Coruña

20122

Milan

28046

Madrid

35128

Padua

44106

Cleveland

44280

Guadalajara

45229

Cincinnati

46026

Valencia

68000

Oaxaca City

70112

New Orleans

70126

Bari

76800

San Juan del Río

95123

Catania

139445

Kazan'

300011

Timișoara

400138

Volgograd

400177

Cluj-Napoca

610027

Kirov

5262000

Ramat Gan

43205-2696

Columbus

B8001HXM

Bahía Blanca

T6G 2C8

Edmonton

L8N 3Z5

Hamilton

M5G 1X8

Toronto

00165

Rome

LV-1004

Riga

08406

Vilnius

Unknown

Oslo

91-738

Lodz

00-576

Warsaw

50-368

Wroclaw

011026

Bucharest

022328

Bucharest

03010

Alicante

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01311648 - BAY81-8973 Pediatric Safety and Efficacy Trial | Biotech Hunter | Biotech Hunter