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recombinant human erythropoietin alfa

Phase 3

Infarction, Middle Cerebral Artery | Small molecule | Neurology |Johnson & Johnson|Trials Updated: Oct 22, 2008

recombinant human erythropoietin alfa development status

Highest phase Phase 3 run by Sandoz (NCT00701714)
Phase scored for JNJPhase 2
Registered trials 4 across 2 sponsors since Jan 2008

recombinant human erythropoietin alfa target and mechanism

Molecular targetF9
Target classExogenous Protein
ModalitySmall molecule

Also known as ERYPO

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment522

FDA Designations

No designations recorded

recombinant human erythropoietin alfa clinical trials

recombinant human erythropoietin alfa · 1 trial · 3 indications

Phase 2 1
NCT00604630Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic StrokeInfarction, Middle Cerebral Artery
COMPLETED522 Analytics
PHASE2COMPLETED
Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke
Infarction, Middle Cerebral ArteryUnlock trial analytics

Study Endpoints

Primary Endpoints

Neurological/functional outcome as measured by the Barthel Index (BI)
day 90

Secondary Endpoints

Modified Rankin Scale (mRS) responder
day 90
Barthel Index (BI)
day 30
mRS
day30, day 90
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placeboPLACEBO_COMPARATOR50ml 0.9% NaCL
verumACTIVE_COMPARATORerythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl

Interventions

NameTypeDescription
recombinant human erythropoietin alfaDRUG40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
0.9% NaClDRUG50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Ischemic stroke in the middle cerebral artery territory * Clearly defined time of onset * Confirmed by MRI (DWI, Flair) * NIH Stroke Scale ≥ 5 * Age \> 18 years * Treatment within 6h after onset of symptoms * Informed consent by patient, relatives or independent physician * Li...

Countries:Germany
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Frequently asked questions about recombinant human erythropoietin alfa

What is recombinant human erythropoietin alfa?

Recombinant human erythropoietin alfa is an investigational exogenous protein being studied by Johnson & Johnson for acute ischemic stroke, specifically infarction of the middle cerebral artery. It has been tested in a single completed Phase 2 clinical trial in Germany. It is not described as approved for this indication.

What is recombinant human erythropoietin alfa used for in middle cerebral artery infarction?

It is being studied as a treatment for acute ischemic stroke caused by middle cerebral artery infarction. The research focuses on patients 18 years and older with acute stroke. The only recorded trial, NCT00604630, has completed, and no active trials are currently listed.

What does recombinant human erythropoietin alfa target?

Recombinant human erythropoietin alfa is an exogenous protein directed at the F9 target. Its target class is classified as an exogenous protein, meaning the drug itself is a protein-based agent rather than a conventional small molecule therapeutic.

Who makes recombinant human erythropoietin alfa?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of recombinant human erythropoietin alfa. The company sponsored the Phase 2 study of the drug in acute ischemic stroke.

What phase is recombinant human erythropoietin alfa in?

Recombinant human erythropoietin alfa is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. It is an investigational therapy and is not described as FDA approved for middle cerebral artery infarction.

What clinical trials is recombinant human erythropoietin alfa in?

Recombinant human erythropoietin alfa has been studied in NCT00604630, a multicenter Phase 2 efficacy study in acute ischemic stroke. The trial was completed in Germany, enrolled 522 patients, and used a randomized, double-blind, placebo-controlled design with participants aged 18 years and older.