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Kogenate

Phase 3

Hemophilia | Small molecule | Hematology |Bayer AG|Trials Updated: Apr 13, 2010

Kogenate target and mechanism

ModalitySmall molecule

Also known as Kogenate (BAY14-2222)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Kogenate clinical trials

Kogenate · 1 trial · 1 indication

Phase 3 1
NCT00606060BAY14-2222 Continuous Infusion in SurgeriesHemophilia
COMPLETED15 Analytics
PHASE3COMPLETED
BAY14-2222 Continuous Infusion in Surgeries
HemophiliaUnlock trial analytics

Study Endpoints

Primary Endpoints

efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
28 days

Secondary Endpoints

Evaluate the safety of rFVIII-FS.
28 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Kogenate (BAY14-2222)DRUG100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients.
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Eligibility Criteria

Age Range12 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Severe hemophilia A (FVIII:C \</=1%) * No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay \< 0.6 BU) * Elective major surgery requiring at least 6 days of rFVIII-FS therapy * Subjects should have been previously treated with F...

Countries:Israel
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Frequently asked questions about Kogenate

What is Kogenate used for?

Kogenate is a hemophilia treatment developed by Bayer AG. It has been studied in a Phase 3 trial in hemophilia patients, specifically evaluating continuous infusion during surgeries. The completed study enrolled 15 male participants aged 12 years and older in Israel.

Who makes Kogenate?

Kogenate is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the clinical development program for this hemophilia therapy, including the Phase 3 study of continuous infusion in surgical settings.

What phase is Kogenate in?

Kogenate has been evaluated in a Phase 3 clinical trial. That study, NCT00606060, is completed. The program includes one trial total, with no active trials currently listed, and enrolled 15 participants.

What clinical trials is Kogenate in?

Kogenate has been studied in one clinical trial, NCT00606060, titled BAY14-2222 Continuous Infusion in Surgeries. It was a Phase 3, completed, uncontrolled study that enrolled 15 male hemophilia patients aged 12 years and older in Israel.

Is Kogenate the same as BAY14-2222?

Yes, Kogenate is also known as BAY14-2222. BAY14-2222 is the compound identifier used in the clinical trial record for Kogenate, the hemophilia therapy developed by Bayer AG. Both names refer to the same investigational asset.