Russian Kogenate Pediatric Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00632814
First received: March 4, 2008
Last updated: March 28, 2014
Last verified: March 2014
  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.


Condition Intervention Phase
Hemophilia A
Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week
Drug: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)
Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Bleeds Per Participant During the 9-month Treatment Period [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
  • Number of Participants With Bleeding Events During the 9-month Treatment Period [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
  • Number of Participants With Joint Bleeds During the 9-month Treatment Period [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
  • Number of Participants in Each Group at the End of the Study [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
  • Actual Monthly rFVIII-FS Consumption [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
  • Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).

  • Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).

  • Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).


Enrollment: 32
Study Start Date: June 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
Experimental: rFVIII-FS (Kogenate FS, BAY14-2222), biw (30 IU/kg + 40 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
Drug: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
Experimental: rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for patients in this group

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Severe hemophilia A or moderate hemophilia A
  • 1-12 years of age
  • Requiring treatment with FVIII

Exclusion Criteria:

  • Current or prior inhibitor or familial antecedents of inhibitor
  • Surgery required during the study (9 months)
  • Positive for HIV
  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: NCT00632814

Locations
Russian Federation
Ekaterinburg, Russian Federation, 620149
Kirov, Russian Federation, 610 027
Moscow, Russian Federation, 105077
St. Petersburg, Russian Federation, 191186
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00632814     History of Changes
Other Study ID Numbers: 12684
Study First Received: March 4, 2008
Results First Received: January 14, 2011
Last Updated: March 28, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Bayer:
Kogenate,
Children,
Factor VIII,
Hemophilia A,
Prophylactic

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 July 23, 2014