Trial Condition(s):

Hemophilia A

Safety and Efficacy of BAY94-9027 in Previously Treated Male Children with Haemophilia A

Bayer Identifier:

15912

ClinicalTrials.gov Identifier:

NCT01775618

EudraCT Number:

2012-004434-42

Study Completed

Trial Purpose

Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting process to be slowed and the person experiences bleeds causing serious problems that could lead to disability. The current standard treatment for severe hemophilia A is infusion of FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day.
In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being evaluated in 50 male subjects, < 12 years of age, with severe Hemophilia A. These subjects will receive open label treatment with long-acting rFVIII for approximately 6 months (or longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and dose intervals may be adapted to the subject's clinical need. A second group of patients will receive open label treatment with the same drug for 12 weeks on a regular schedule of 2x/week. Patients will attend the treatment center for routine blood samples and will be required to keep an electronic diary.
Subjects will be offered participation in an optional extension study to collect observations for at least an additional 50 exposure days.

Inclusion Criteria
- Males < 12 years of age
 - Subjects with severe hemophilia A
 - Previously treated with FVIII for > 50 exposure days
Exclusion Criteria
- Subjects with current evidence of or history of inhibitors to FVIII
 - Any other inherited or acquired bleeding disorder
 - Platelet counts < 100,000/mm^3
 - Creatinine > 2x the upper limit of normal
 - Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) > 5x the upper limit of normal

Trial Summary

Enrollment Goal
73
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Jivi (Damoctocog, BAY94-9027)
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
 
Locations

Investigative Site

Palermo, Italy, 90127

Status
Completed
 
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Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
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Investigative Site

UTRECHT, Netherlands, 3584 CX

Status
Completed
 
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Investigative Site

AMSTERDAM, Netherlands

Status
Completed
 
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Investigative Site

Columbus, United States, 43205-2696

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

Sofia, Bulgaria, 1527

Status
Completed
 
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Investigative Site

Cincinnati, United States, 45229

Status
Completed
 
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Investigative Site

Cleveland, United States, 44106-6007

Status
Completed
 
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Investigative Site

Hershey, United States, 17033

Status
Completed
 
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Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
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Investigative Site

La Plata, Argentina, 1900

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

GENT, Belgium, 9000

Status
Completed
 
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Investigative Site

Newcastle Upon Tyne, United Kingdom, NE1 4LP

Status
Completed
 
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Investigative Site

Lodz, Poland, 91-738

Status
Completed
 
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Investigative Site

Olsztyn, Poland, 10-561

Status
Completed
 
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Investigative Site

Vilnius, Lithuania, 08661

Status
Completed
 
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Investigative Site

Sacramento, United States, 95817

Status
Completed
 
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Investigative Site

Manchester, United Kingdom, M13 9WL

Status
Completed
 
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Investigative Site

Sheffield, United Kingdom, S10 2TH

Status
Completed
 
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Investigative Site

Toronto, Canada, M5G 1X8

Status
Completed
 
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Investigative Site

Calgary, Canada, T3B 6A8

Status
Completed
 
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Investigative Site

Wien, Austria, 1090

Status
Completed
 
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Investigative Site

Pensacola, United States, 32504

Status
Completed
 
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Investigative Site

Bristol, United Kingdom, BS2 8AE

Status
Completed
 
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Investigative Site

Esplugues de LLobregat, Spain, 08950

Status
Completed
 
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Investigative Site

Christchurch, New Zealand, 8011

Status
Completed
 
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Investigative Site

Oslo, Norway, 0027

Status
Completed
 
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Investigative Site

Thessaloniki, Greece, 54642

Status
Completed
 
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Investigative Site

Hamilton, New Zealand, 3204

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84113

Status
Completed
 

Trial Design