Trial Condition(s):

Haemophilia A

BAY81-8973 pediatric safety and efficacy trial

Bayer Identifier:

13400

ClinicalTrials.gov Identifier:

NCT01311648

EudraCT Number:

2010-021781-29

Study Completed

Trial Purpose

The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A.

The secondary objectives were
- To assess the safety and efficacy of BAY81-8973 during surgeries.
- To assess incremental recovery of BAY81-8973.
- To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated patients [PTPs] and previously untreated patients [PUPs] / minimally treated patients [MTPs] - participation in PK sampling was voluntary and required consent).

Inclusion Criteria
- Male
- PTPs (previously treated patients): aged <= 12 years
- PUPs (previously untreated patients) / MTPs (minimally treated patients): aged < 6 years
- Severe hemophilia A defined as < 1% FVIII concentration (FVIII:C)
- PTPs: >= 50 exposure days (EDs) with any FVIII concentrate, no current evidence of inhibitory antibody, and no history of FVIII inhibitor formation
- PUPs: no prior exposure to any FVIII product
- MTPs: having no more than 3 EDs with any FVIII product, no current evidence of inhibitory antibody and no history of FVIII inhibitor formation
Exclusion Criteria
- With another bleeding disorder that is different from Hemophilia A
- With thrombocytopenia (platelet count < 100 000/mm^3)
- Creatinine > 2x upper limit of normal or Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > 5x upper limit of normal
- Without a negative inhibitor testing at screening (except for PUPs)
- Receiving chemotherapy, immune modulatory drugs, has received another investigational FVIII product within the last month, or received another experimental drug within the last 3 months
- Requires any pre-medication to tolerate FVIII treatment
- Known hypersensitivity to active substance, mouse, or hamster protein

Trial Summary

Enrollment Goal
94
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
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Investigative Site

Roma, Italy, 00165

Status
Completed
 
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Investigative Site

Timisoara, Romania, 300011

Status
Completed
 
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Investigative Site

Bucharest, Romania, 011026

Status
Completed
 
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Investigative Site

Bucharest, Romania, 022328

Status
Completed
 
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Investigative Site

Mohacs, Hungary, 7700

Status
Completed
 
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Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
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Investigative Site

Budapest, Hungary, 1089

Status
Completed
 
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Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
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Investigative Site

Varna, Bulgaria, 9010

Status
Completed
 
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Investigative Site

Plovdiv, Bulgaria, 4002

Status
Completed
 
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Investigative Site

Vilnius, Lithuania, 08406

Status
Completed
 
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Investigative Site

Wroclaw, Poland, 50-368

Status
Completed
 
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Investigative Site

Warszawa, Poland, 00-576

Status
Completed
 
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Investigative Site

Riga, Latvia, LV-1004

Status
Completed
 
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Investigative Site

Lodz, Poland, 91-738

Status
Completed
 
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Investigative Site

Århus N, Denmark, 8200

Status
Completed
 
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Investigative Site

Columbus, United States, 43205-2696

Status
Completed
 
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Investigative Site

Toronto, Canada, M5G 1X8

Status
Completed
 
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Investigative Site

Edmonton, Canada, T6G 2C8

Status
Completed
 
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Investigative Site

Crumlin, Ireland, 12

Status
Completed
 
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Investigative Site

Cleveland, United States, 44106

Status
Completed
 
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Investigative Site

Cincinnati, United States, 45229

Status
Completed
 
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Investigative Site

New Orleans, United States, 70112

Status
Completed
 
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Investigative Site

Cluj-Napoca, Romania, 400177

Status
Completed
 
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Hamilton, Canada, L8N 3Z5

Status
Completed
 
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Bari, Italy, 70126

Status
Completed
 
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Investigative Site

Oaxaca, Mexico, 68000

Status
Completed
 
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Investigative Site

Guadalajara, Mexico, 44280

Status
Completed
 
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Investigative Site

Madrid, Spain, 28046

Status
Completed
 
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Investigative Site

A Coruña, Spain, 15006

Status
Completed
 
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Investigative Site

Valencia, Spain, 46026

Status
Completed
 
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Investigative Site

Kirov, Russia, 610027

Status
Completed
 
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Investigative Site

Kazan, Russia, 139445

Status
Completed
 
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Investigative Site

Bahía Blanca, Argentina, B8001HXM

Status
Completed
 
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Investigative Site

Esplugues de LLobregat, Spain, 08950

Status
Completed
 
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Investigative Site

Volgograd, Russia, 400138

Status
Completed
 
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Investigative Site

San Juan del Río, Mexico, 76800

Status
Completed
 
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Investigative Site

Oslo, Norway

Status
Completed
 
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Investigative Site

Cáceres, Spain, 10003

Status
Completed
 
Locations

Investigative Site

Alicante, Spain, 03010

Status
Completed
 
Locations

Investigative Site

Catania, Italy, 95123

Status
Completed
 

Trial Design