Hemophilia APhase 4NCT00632814

Russian Kogenate Pediatric Study

A Phase 4 study testing 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) and rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg) in people with Hemophilia A, run by Bayer at 4 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 1 year to 12 years, men only
Conditions the study is for: Hemophilia A
What is being tested?: 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) and rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 4 sitesRussia
Study dates: Jun 2007to Sep 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 12 years
Men only
No healthy volunteers
Child

Who may be able to join

Male
Severe hemophilia A or moderate hemophilia A
1-12 years of age
Requiring treatment with FVIII

Who cannot join

Current or prior inhibitor or familial antecedents of inhibitor
Surgery required during the study (9 months)
Positive for HIV

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

Study site
Kirov, 610 027
Study site
Moscow, 105077
Study site
Saint Petersburg, 191186
Study site
Yekaterinburg, 620149

Other trials in Russia

About this 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.

Conditions: Hemophilia A
Being tested: 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)
Keywords: Kogenate,, Children,, Factor VIII,, Hemophilia A,, Prophylactic
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00632814
Study group	Role	What they receive
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw	Experimental	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) Receives: Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week
rFVIII-FS (Kogenate FS, BAY14-2222), biw (30 IU/kg + 40 IU/kg)	Experimental	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) Receives: Drug: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)
rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg)	Experimental	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 Receives: Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

Number of Bleeds Per Participant During the 9-month Treatment Period
Measured: Up to 9 months
Number of Participants With Bleeding Events During the 9-month Treatment Period
Measured: Up to 9 months
Number of Participants With Joint Bleeds During the 9-month Treatment Period
Measured: Up to 9 months
Number of Participants in Each Group at the End of the Study
Measured: Up to 9 months
Actual Monthly rFVIII-FS Consumption
Measured: Up to 9 months
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).
Measured: baseline and 9 months
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).
Measured: 9 months
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).
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Sep 2009

First posted11 Mar 2008 (estimated)
Study startJun 2007
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hemophilia AStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00632814
Sponsor's protocol ID: 12684
Other IDs: 2014-005253-39, 2014
Status last verified: Jun 2015
First submitted: 4 Mar 2008
Last updated: 1 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Hemophilia A, Healthy Adult Participants
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Hemophilia A

All Hemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00632814
Acronym / sponsor ID: 12684
Conditions: Hemophilia A
Keywords: Kogenate,, Children,, Factor VIII,, Hemophilia A,, Prophylactic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 11 Mar 2008 (estimated)
Results: Posted 8 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw	Experimental	Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per weekrFVIII-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)	Experimental	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 [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)	Experimental	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 [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group

Who may qualify

Ages: 1 year to 12 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male
Severe hemophilia A or moderate hemophilia A
1-12 years of age
Requiring treatment with FVIII

Key exclusion criteria (3 listed)

Current or prior inhibitor or familial antecedents of inhibitor
Surgery required during the study (9 months)
Positive for HIV

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per weekrFVIII-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)	Drug	rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
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)	Drug	rFVIII-FS (Kogenate FS, BAY14-2222), biw (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)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	Drug	rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg)

Primary outcome

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

8 secondary outcomes

Number of Bleeds Per Participant During the 9-month Treatment Period
Time frame: Up to 9 months
Number of Participants With Bleeding Events During the 9-month Treatment Period
Time frame: Up to 9 months
Number of Participants With Joint Bleeds During the 9-month Treatment Period
Time frame: Up to 9 months
Number of Participants in Each Group at the End of the Study
Time frame: Up to 9 months
Actual Monthly rFVIII-FS Consumption
Time frame: Up to 9 months
Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment
Time frame: baseline and 9 months
Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)
Time frame: 9 months
Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment
Time frame: 9 months

Results and safety

Results posted to the registry on 8 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw	11	11
rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)	13	13
rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)	8	8

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

Time frame: Up to 9 months. Number. Unit: Percentage of participants

Measure	rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw n = 11	rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg) n = 13	rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg) n = 8
Value	72.7	84.6	75.0

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw	1 of 11 (9.1%)	4 of 11 (36.4%)	Not reported
rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)	2 of 13 (15.4%)	3 of 13 (23.1%)	Not reported
rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationV.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
Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.

Related trials for Hemophilia A

RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Hemophilia A, Healthy Adult Participants
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
RecruitingPhase 3
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RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00632814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015; AzTrials last refreshed its copy on 29 Oct 2026.