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rFIX

Phase 3

Hemophilia B | Small molecule | Hematology |Pfizer, Inc.|Last Updated: Aug 21, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

rFIX · 2 trials · 1 indication

Phase 3 2
NCT00093171Study Evaluating rFIX; BeneFIX® in Hemophilia BHemophilia B
COMPLETED23 Analytics
NCT00093210Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia BHemophilia B
COMPLETED- Analytics
PHASE3COMPLETED
Study Evaluating rFIX; BeneFIX® in Hemophilia B
Hemophilia BUnlock trial analytics
PHASE3COMPLETED
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B
Hemophilia BUnlock trial analytics

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
PurposeTREATMENT

Interventions

NameTypeDescription
rFIXDRUG -
rFIX-RDRUG -
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Hemophilia B (FIX:C less than 2%) * Previous treatment of at least 150 exposure days using any FIX product * 12 years of age and older Exclusion Criteria: * The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors...

Countries:United States
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Frequently asked questions about rFIX

What is rFIX used for in Hemophilia B?

rFIX is a recombinant factor IX therapy used for the treatment of Hemophilia B, a bleeding disorder caused by a deficiency of clotting factor IX. It is being developed by Pfizer, Inc. and is currently in Phase 3 clinical development, meaning it is investigational and not yet approved.

Who makes rFIX?

rFIX is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical trials for the treatment of Hemophilia B.

What phase is rFIX in?

rFIX is in Phase 3 clinical development for the treatment of Hemophilia B. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 23 participants in one of the studies.

What clinical trials is rFIX in?

rFIX has been studied in two completed Phase 3 clinical trials. The first, NCT00093171, evaluated rFIX (BeneFIX) in Hemophilia B with 23 participants aged 12 years and older in the United States. The second, NCT00093210, evaluated recombinant human factor IX (BeneFIX) and a new formulation (rFIX-R) in moderate to severe Hemophilia B.

Is rFIX the same as BeneFIX?

Yes, rFIX is also known as BeneFIX. The clinical trials NCT00093171 and NCT00093210 refer to rFIX as BeneFIX, and the second trial also evaluates a new formulation called rFIX-R. Both are recombinant factor IX products for Hemophilia B.