Russian Kogenate Pediatric Study

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00632814

First received: March 4, 2008

Last updated: April 9, 2013

Last verified: April 2013

History of Changes

Results First Received: January 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hemophilia A
Interventions:	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)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was an indefinite time period between screening and baseline. Study treatment started at visit 2 (baseline).

Reporting Groups

	Description
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

Participant Flow: Overall Study

	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)
STARTED	11	13	8
COMPLETED	11	13	8
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	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)	Total
Number of Participants [units: participants]	11	13	8	32
Age [units: years] Mean ± Standard Deviation	3.27 ± 3.20	6.08 ± 3.50	6.00 ± 3.12	5.09 ± 3.47
Gender [units: participants]
Female	0	0	0	0
Male	11	13	8	32
Ethnicity [units: participants]
Caucasian	11	13	7	31
Asian	0	0	1	1
Body Weight [units: Kilograms] Mean ± Standard Deviation	17.48 ± 10.43	24.39 ± 11.35	25.45 ± 9.87	22.28 ± 10.93
Height [units: Centimeters] Mean ± Standard Deviation	98.09 ± 22.88	120.31 ± 23.75	122.00 ± 20.74	113.09 ± 24.63
Number of participants on Prophylaxis Prior to Screening ^[1] [units: pariticipants]
On demand	9	6	5	20
Prophylaxis	2	7	3	12
FVIII trough level at Baseline [units: Percentage of FVIII activity] Mean ± Standard Deviation	1.43 ± 0.70	1.62 ± 1.79	0.77 ± 0.24	1.34 ± 1.24
Number of participants with different exposure days (ED) [units: participants]
0 ED	1	0	0	1
1 to <20 ED	1	0	0	1
20 to <100 ED	4	2	4	10
>=100 ED	5	11	4	20
Percentage of participants with Target Joint Present [units: Percentage of participants]	36	54	88	178
Number of participants with bleeding rates in previous 6-9 Months [units: participants]
No bleedings	1	2	0	3
Any bleedings	10	11	8	29
Any joint bleedings	9	11	6	26
Stockholm Joint Score ^[2] [units: scores on a scale] Mean ± Standard Deviation	3.9 ± 4.8	5.9 ± 5.8	7.1 ± 4.6	5.5 ± 5.2

[1]	Number of participants on prophylaxis versus on-demand therapy before screening
[2]	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).

Outcome Measures

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1. Primary:

Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period [ Time Frame: Up to 9 months ]

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2. Secondary:

Number of Bleeds Per Participant During the 9-month Treatment Period [ Time Frame: Up to 9 months ]

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3. Secondary:

Number of Participants With Bleeding Events During the 9-month Treatment Period [ Time Frame: Up to 9 months ]

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4. Secondary:

Number of Participants With Joint Bleeds During the 9-month Treatment Period [ Time Frame: Up to 9 months ]

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5. Secondary:

Number of Participants in Each Group at the End of the Study [ Time Frame: Up to 9 months ]

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6. Secondary:

Actual Monthly rFVIII-FS Consumption [ Time Frame: Up to 9 months ]

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7. Secondary:

Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment [ Time Frame: baseline and 9 months ]

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8. Secondary:

Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group) [ Time Frame: 9 months ]

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9. Secondary:

Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment [ Time Frame: 9 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Protocol deviations were not excluded: e.g. a previously untreated patient developed the transitory inhibitor; change to a higher group did not always occur according protocol; there was temporary lack of smaller vial sizes at the centers.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
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:	April 9, 2013
Health Authority:	Russia: Ministry of Health of the Russian Federation

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