Back to results

Russian Kogenate Pediatric Study

Primary Purpose

Hemophilia A

Status

Completed

Phase

Phase 4

Locations

Russian Federation

Study Type

Interventional

Intervention

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

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

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

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring Kogenate,, Children,, Factor VIII,, Hemophilia A,, Prophylactic

Eligibility Criteria

1 Year - 12 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw

rFVIII-FS (Kogenate FS, BAY14-2222), biw (30 IU/kg + 40 IU/kg)

rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg)

Arm Description

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)

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Actual Monthly rFVIII-FS Consumption

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

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)

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

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).

Full Information

NCT ID

NCT00632814

First Posted

March 4, 2008

Last Updated

June 4, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00632814

Brief Title

Russian Kogenate Pediatric Study

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

Keywords

Kogenate,, Children,, Factor VIII,, Hemophilia A,, Prophylactic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw

Arm Type

Experimental

Arm Description

Arm Title

rFVIII-FS (Kogenate FS, BAY14-2222), biw (30 IU/kg + 40 IU/kg)

Arm Type

Experimental

Arm Description

Arm Title

rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

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

Time Frame

Up to 9 months

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 9 months

Title

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

Time Frame

Up to 9 months

Title

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

Time Frame

Up to 9 months

Title

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

Time Frame

Up to 9 months

Title

Actual Monthly rFVIII-FS Consumption

Time Frame

Up to 9 months

Title

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

Description

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).

Time Frame

baseline and 9 months

Title

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

Description

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).

Time Frame

9 months

Title

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

Description

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).

Time Frame

9 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Ekaterinburg

ZIP/Postal Code

620149

Country

Russian Federation

City

Kirov

ZIP/Postal Code

610 027

Country

Russian Federation

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

City

St. Petersburg

ZIP/Postal Code

191186

Country

Russian Federation

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

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

Learn more about this trial

Russian Kogenate Pediatric Study

We'll reach out to this number within 24 hrs