Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01810666
First received: March 12, 2013
Last updated: March 31, 2014
Last verified: April 2014
  Purpose

Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.


Condition Intervention Phase
Hemophilia A
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of bleeds during on-demand and prophylaxis treatment periods [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of joint bleeds during on-demand and prophylaxis treatment periods [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Joint function assessed by the Hemophilia Joint Health Score [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recombinant Factor VIII Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
On-demand treatment phase for 12 weeks will be followed by 12 weeks prophylaxis treatment phase. The dose in on-demand treatment will be decided by physician according to the package insert or the current standard of care. The dose and mode of prophylaxis treatment will be 25 IU/Kg, 3 times/per week.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, aged 2-16yrs
  • Severe hemophilia A (<1% FVIII:C [Blood Clotting Factor VIII:C] )
  • Minimum of at least 50 documented ED (exposure day) prior to enrolment
  • No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation
  • Parents or legal guardians document, sign, and date informed consent

Exclusion Criteria:

  • Another bleeding disease that is different from hemophilia A
  • Known hypersensitivity to the active substance, mouse or hamster protein
  • Thrombocytopenia (platelet count <100 000/mm3) based on previous medical records
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810666

Locations
China, Guangdong
Guangzhou, Guangdong, China, 510515
China, Hubei
Wuhan, Hubei, China, 430022
China
Beijing, China, 100730
Beijing, China
Tianjin, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01810666     History of Changes
Other Study ID Numbers: 16287, 2014-001362-10
Study First Received: March 12, 2013
Last Updated: March 31, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014