Trial Outcomes & Findings for Russian Kogenate Pediatric Study (NCT NCT00632814)
NCT ID: NCT00632814
Last Updated: 2015-07-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2015-07-01
Participant Flow
The recruitment period took from first patient first visit 28 Jun 2007 to last patient first visit 26 Dec 2008. The study period took from first patient first visit 28 Jun 2007 to last patient last visit 27 Sep 2009. All 4 sites were medical clinics. Assignment to a group was based on patients previous treatment schedule (non-randomized).
There was an indefinite time period between screening and baseline. Study treatment started at visit 2 (baseline).
Participant milestones
| Measure |
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)
|
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)
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
8
|
|
Overall Study
COMPLETED
|
11
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Russian Kogenate Pediatric Study
Baseline characteristics by cohort
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.27 years
STANDARD_DEVIATION 3.20 • n=5 Participants
|
6.08 years
STANDARD_DEVIATION 3.50 • n=7 Participants
|
6.00 years
STANDARD_DEVIATION 3.12 • n=5 Participants
|
5.09 years
STANDARD_DEVIATION 3.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity
Caucasian
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
7 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Ethnicity
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Body Weight
|
17.48 Kilograms
STANDARD_DEVIATION 10.43 • n=5 Participants
|
24.39 Kilograms
STANDARD_DEVIATION 11.35 • n=7 Participants
|
25.45 Kilograms
STANDARD_DEVIATION 9.87 • n=5 Participants
|
22.28 Kilograms
STANDARD_DEVIATION 10.93 • n=4 Participants
|
|
Height
|
98.09 Centimeters
STANDARD_DEVIATION 22.88 • n=5 Participants
|
120.31 Centimeters
STANDARD_DEVIATION 23.75 • n=7 Participants
|
122.00 Centimeters
STANDARD_DEVIATION 20.74 • n=5 Participants
|
113.09 Centimeters
STANDARD_DEVIATION 24.63 • n=4 Participants
|
|
Number of participants on Prophylaxis Prior to Screening
On demand
|
9 pariticipants
n=5 Participants
|
6 pariticipants
n=7 Participants
|
5 pariticipants
n=5 Participants
|
20 pariticipants
n=4 Participants
|
|
Number of participants on Prophylaxis Prior to Screening
Prophylaxis
|
2 pariticipants
n=5 Participants
|
7 pariticipants
n=7 Participants
|
3 pariticipants
n=5 Participants
|
12 pariticipants
n=4 Participants
|
|
FVIII trough level at Baseline
|
1.43 Percentage of FVIII activity
STANDARD_DEVIATION 0.70 • n=5 Participants
|
1.62 Percentage of FVIII activity
STANDARD_DEVIATION 1.79 • n=7 Participants
|
0.77 Percentage of FVIII activity
STANDARD_DEVIATION 0.24 • n=5 Participants
|
1.34 Percentage of FVIII activity
STANDARD_DEVIATION 1.24 • n=4 Participants
|
|
Number of participants with different exposure days (ED)
0 ED
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Number of participants with different exposure days (ED)
1 to <20 ED
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Number of participants with different exposure days (ED)
20 to <100 ED
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Number of participants with different exposure days (ED)
>=100 ED
|
5 participants
n=5 Participants
|
11 participants
n=7 Participants
|
4 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Percentage of participants with Target Joint Present
|
36 Percentage of participants
n=5 Participants
|
54 Percentage of participants
n=7 Participants
|
88 Percentage of participants
n=5 Participants
|
178 Percentage of participants
n=4 Participants
|
|
Number of participants with bleeding rates in previous 6-9 Months
No bleedings
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Number of participants with bleeding rates in previous 6-9 Months
Any bleedings
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Number of participants with bleeding rates in previous 6-9 Months
Any joint bleedings
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Stockholm Joint Score
|
3.9 scores on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
5.9 scores on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
7.1 scores on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
5.5 scores on a scale
STANDARD_DEVIATION 5.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsOutcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
|---|---|---|---|
|
Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period
|
72.7 Percentage of participants
|
84.6 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsOutcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
|---|---|---|---|
|
Number of Bleeds Per Participant During the 9-month Treatment Period
All bleeds
|
3.0 bleeds per participant
Interval 0.0 to 12.0
|
2.0 bleeds per participant
Interval 0.0 to 6.0
|
1.5 bleeds per participant
Interval 0.0 to 8.0
|
|
Number of Bleeds Per Participant During the 9-month Treatment Period
Joint bleeds
|
0 bleeds per participant
Interval 0.0 to 2.0
|
0 bleeds per participant
Interval 0.0 to 3.0
|
0 bleeds per participant
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 9 monthsOutcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
|---|---|---|---|
|
Number of Participants With Bleeding Events During the 9-month Treatment Period
no bleeds
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Bleeding Events During the 9-month Treatment Period
bleeds at all
|
8 Participants
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsOutcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
|---|---|---|---|
|
Number of Participants With Joint Bleeds During the 9-month Treatment Period
no bleeds
|
8 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Joint Bleeds During the 9-month Treatment Period
bleeds at all
|
3 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: Participants were allowed to switch treatment groups upon occurrence of joint bleed. Therefore the number of participants per group at the end of the study is different from the number of participants per group at baseline.
Outcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
|---|---|---|---|
|
Number of Participants in Each Group at the End of the Study
|
8 Participants
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsOutcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
|---|---|---|---|
|
Actual Monthly rFVIII-FS Consumption
|
390.8 IU/kg
Standard Deviation 106.9
|
422.3 IU/kg
Standard Deviation 138.2
|
501.4 IU/kg
Standard Deviation 241.2
|
SECONDARY outcome
Timeframe: baseline and 9 monthsThe 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).
Outcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 Participants
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
|
|---|---|---|---|
|
Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment
|
-1.4 Scores on a scale
Standard Deviation 2.4
|
-2.0 Scores on a scale
Standard Deviation 4.5
|
-1.8 Scores on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants who completed the questionnaire.
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).
Outcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=3 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=10 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=7 Participants
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
|
|---|---|---|---|
|
Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)
|
30.28 Scores on a scale
Standard Deviation 13.09
|
39.07 Scores on a scale
Standard Deviation 23.50
|
30.27 Scores on a scale
Standard Deviation 11.95
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants who completed the questionnaire.
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).
Outcome measures
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=3 Participants
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=10 Participants
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=7 Participants
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
|
|---|---|---|---|
|
Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment
|
29.13 Scores on a scale
Standard Deviation 17.40
|
28.43 Scores on a scale
Standard Deviation 10.27
|
31.38 Scores on a scale
Standard Deviation 13.06
|
Adverse Events
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 participants at risk
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 participants at risk
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 participants at risk
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
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Ear infection
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
Other adverse events
| Measure |
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
n=11 participants at risk
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 (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)
n=13 participants at risk
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 (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)
n=8 participants at risk
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
|
|---|---|---|---|
|
Infections and infestations
Adenoiditis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
0.00%
0/8
|
|
Infections and infestations
Respiratory tract infection viral
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
0.00%
0/8
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/11
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Varicella
|
0.00%
0/11
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Yersinia infection
|
0.00%
0/11
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 2
|
0.00%
0/13
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/11
|
0.00%
0/13
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/11
|
0.00%
0/13
|
12.5%
1/8 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institute shall supply a draft of any intended publication to the Customer not less than 60 (sixty) days before submission it for the publication in question and will supply a draft of any abstract or detailed paper or oral statement intended for public presentation not less than 60 (sixty) days before the earliest of the date of submission of the abstract or delivery of the public presentation. The Institute agrees that in any such publication only such data as is contained in an analysis.
- Publication restrictions are in place
Restriction type: OTHER