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BAY81-8973 Pediatric Safety and Efficacy Trial

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01311648
First received: February 18, 2011
Last updated: September 15, 2017
Last verified: September 2017
  Purpose
The objective of the study is to demonstrate the safety and efficacy of treatment with BAY81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.

Condition Intervention Phase
Haemophilia A Biological: Recombinant Factor VIII (BAY81-8973) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase III Uncontrolled Open-label Trial to Evaluate Safety and Efficacy of BAY81-8973 in Children With Severe Hemophilia A Under Prophylaxis Therapy

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Annualized number of bleeds within 48 hours (h) after a prophylaxis injection [ Time Frame: Up to 9 months ]

Secondary Outcome Measures:
  • Incidence of inhibitory antibody [ Time Frame: Up to 9 months ]
  • Total annualized consumption of FVIII per subject [ Time Frame: Up to 9 months ]
  • Number of infusions for the treatment of a bleed [ Time Frame: Up to 9 months ]
  • Recovery of FVIII after infusion [ Time Frame: Up to 9 months ]

Estimated Enrollment: 101
Actual Study Start Date: June 9, 2011
Estimated Study Completion Date: December 31, 2022
Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
PTPs prophylaxis treatment 25-50 IU/kg at least 2x/week. PUPs 15 -50 IU/kg at least 1x/week.
Biological: Recombinant Factor VIII (BAY81-8973)
PTPs prophylaxis treatment 25-50 IU/kg at least 2x/week. PUPs 15 -50 IU/kg at least 1x/week.

  Eligibility

Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, aged </= 12 years
  • Severe hemophilia A defined as < 1% FVIII:C
  • PTPs (previously treated patients) > 50 Exposure days (ED) with any high purity FVIII, or
  • PUPs (previously untreated patients) no prior exposure to any high purity FVIII
  • MTPs (minimally treated patients) not previously having received more than 3 injections with any FVIII concentrate
  • No current evidence or history of inhibitory antibody

Exclusion Criteria:

  • History of FVIII inhibitor formation
  • Diagnosed with other bleeding disorder
  • Platelet count < 100000 cells/μL
  • Kidney or liver dysfunction
  • Known hypersensitivity to any FVIII
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311648

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 67 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01311648     History of Changes
Other Study ID Numbers: 13400
2010-021781-29 ( EudraCT Number )
Study First Received: February 18, 2011
Last Updated: September 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
recombinant factor VIII
pediatric use

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

ClinicalTrials.gov processed this record on September 21, 2017