Russian Kogenate Pediatric Study

NCT ID: NCT00632814

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

Conditions

Hemophilia A

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

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

Intervention Type: 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), 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)

Group Type: EXPERIMENTAL

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

Intervention Type: 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), 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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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)

Intervention Type: 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)

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Kirov, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Yekaterinburg, , Russia

Countries

Russia

References

V.V. Vdovin, T.A. Andreeva, T.A. Chernova, F.G. Perina, E.E.M. Shiller, P.V. Svirin, M. Maas Enriquez, and S. Rauchensteiner. Prophylaxis with Once, Twice or Three-Times Weekly Dosing of rFVIII-FS Prevents Joint Bleeds in a Previously Treated Pediatric Population with Moderate/Severe Hemophilia A. Journal of Coagulation Disorders 2011; 3:(1). October 2011

Reference Type: RESULT

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2014-005253-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12684

Identifier Type: -

Identifier Source: org_study_id