check_circleStudy Completed

Hemophilia A

Bayer Identifier:

12684

ClinicalTrials.gov Identifier:

NCT00632814

EudraCT Number:

2014-005253-39

EU CT Number:

Not Available
Russian Kogenate Pediatric Study

Trial purpose

A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.

Key Participants Requirements

Sex

Male

Age

1 - 12 Years
  • - Male
    - Severe hemophilia A or moderate hemophilia A
    - 1-12 years of age
    - Requiring treatment with FVIII
  • - Current or prior inhibitor or familial antecedents of inhibitor
    - Surgery required during the study (9 months)
    - Positive for HIV

Trial summary

Enrollment Goal
32
Trial Dates
June 2007 - September 2009
Phase
Phase 4
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Izamaylovska Children's HospitalMoscow, 105077, Russia
Completed
Children's Center of Oncology and HematologyEkaterinburg, 620149, Russia
Completed
Hemophilia CentreSt. Petersburg, 191186, Russia
Completed
Scientific Research Institute of hematology and blood tranf.Kirov, 610 027, Russia

Primary Outcome

  • Percentage of participants with less than 2 joint bleeds during the 9-month treatment period
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Number of bleeds per participant during the 9-month treatment period
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    yes
  • Number of participants with bleeding events during the 9-month treatment period
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    yes
  • Number of participants with joint bleeds during the 9-month treatment period
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    yes
  • Number of participants in each group at the end of the study
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Actual monthly rFVIII-FS consumption
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Stockholm Hemophilia Joint Score at 9 months of treatment
    date_rangeTime Frame:
    baseline and 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Haemo-QoL standardized total Score at 9 months of treatment (completed by participants in the total group)
    date_rangeTime Frame:
    9 months
    enhanced_encryption
    Safety Issue:
    No
  • Haemo-QoL standardized total Score (completed by parents/caregivers in the total group) at 9 months of treatment
    date_rangeTime Frame:
    9 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe