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Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01810666
First Posted: March 13, 2013
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period [ Time Frame: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) ]
    Annualized bleedings period 1 minus period 2 ITT analysis set.


Secondary Outcome Measures:
  • Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period [ Time Frame: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) ]
    Annualized joint bleedings period 1 minus period 2 ITT analysis set.

  • Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period [ Time Frame: From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment) ]
    Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set.


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)
Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01810666     History of Changes
Other Study ID Numbers: 16287
2014-001362-10 ( EudraCT Number )
First Submitted: March 12, 2013
First Posted: March 13, 2013
Results First Submitted: December 22, 2014
Results First Posted: January 5, 2015
Last Update Posted: May 19, 2015
Last Verified: April 2015

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


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