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recombinant human erythropoietin alfa

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment522

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Recombinant human erythropoietin alfa is being studied for use in infarction of the middle cerebral artery, a type of acute ischemic stroke. It is an investigational therapy in Phase 2 clinical development for this neurological condition, and it is not yet approved for this use.

Who makes recombinant human erythropoietin alfa?

Recombinant human erythropoietin alfa is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research to evaluate the drug's safety and efficacy for acute ischemic stroke.

What phase is recombinant human erythropoietin alfa in?

Recombinant human erythropoietin alfa is in Phase 2 clinical development for infarction of the middle cerebral artery. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials.

What clinical trials is recombinant human erythropoietin alfa in?

Recombinant human erythropoietin alfa has one completed clinical trial, registered as NCT00604630. This Phase 2 study, titled "Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke," enrolled 522 participants in Germany and was a randomized, double-blind, placebo-controlled trial.

Is recombinant human erythropoietin alfa the same as erythropoietin?

Recombinant human erythropoietin alfa is a form of erythropoietin, a hormone that stimulates red blood cell production. In this context, it is being investigated as a potential treatment for acute ischemic stroke, specifically infarction of the middle cerebral artery, rather than for anemia.