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Completed

NCT Number: NCT00632814

Russian Kogenate Pediatric Study

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

1 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Kirov, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week

Drug

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)

rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)

Drug

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)

rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)

Drug

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

Primary outcomes

  1. Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period

    Time frame: Up to 9 months

Secondary outcomes

  1. Number of Bleeds Per Participant During the 9-month Treatment Period

    Time frame: Up to 9 months

  2. Number of Participants With Bleeding Events During the 9-month Treatment Period

    Time frame: Up to 9 months

  3. Number of Participants With Joint Bleeds During the 9-month Treatment Period

    Time frame: Up to 9 months

  4. Number of Participants in Each Group at the End of the Study

    Time frame: Up to 9 months

  5. Actual Monthly rFVIII-FS Consumption

    Time frame: Up to 9 months

  6. Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment

    Time frame: baseline and 9 months

    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).

  7. Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)

    Time frame: 9 months

    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).

  8. Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment

    Time frame: 9 months

    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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 11, 2008
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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