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r-HuEPO

Phase 3

Anemia | Small molecule | Hematology |Roche Holding AG|Last Updated: Apr 4, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

r-HuEPO · 1 trial · 1 indication

Phase 3 1
NCT02767765A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With ChemotherapyAnemia
COMPLETED61 Analytics
PHASE3COMPLETED
A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy
AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Response to Treatment
Week 4

Response to treatment was defined as an increase of greater than (\>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.

Secondary Endpoints

Time to Response
Baseline up to Week 4
Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment
Week 2
Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment
Week 4
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
r-HuEPOEXPERIMENTALAnemic cancer participants will receive r-HuEPO for 4 weeks.

Interventions

NameTypeDescription
r-HuEPODRUGAll participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histological or cytological confirmed cancer * Participants who are treated with at least first line chemotherapy * Hemoglobin less than (\<) 11 grams per deciliter (g/dL) * Participants able to receive iron supplement, if necessary Exclusion Criteria: * History of hypersens...

Countries:Italy
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Frequently asked questions about r-HuEPO

What is r-HuEPO used for?

r-HuEPO is used for anemia, specifically in anemic cancer patients treated with chemotherapy. It is a recombinant human erythropoietin being developed by Roche Holding AG. The drug is currently in Phase 3 clinical development for this indication.

What does r-HuEPO target?

r-HuEPO is a recombinant human erythropoietin, which targets the erythropoietin receptor to stimulate red blood cell production. This mechanism helps treat anemia by increasing hemoglobin levels in patients.

Who makes r-HuEPO?

r-HuEPO is developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker RHHBY on the OTC market. The drug is being studied for the treatment of anemia in cancer patients undergoing chemotherapy.

What phase is r-HuEPO in?

r-HuEPO is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 3 study has been completed to evaluate its safety and efficacy in anemic cancer patients receiving chemotherapy.

What clinical trials is r-HuEPO in?

r-HuEPO has one completed Phase 3 clinical trial, NCT02767765, titled 'A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy.' This trial enrolled 61 participants in Italy and was completed.

Is r-HuEPO the same as NeoRecormon?

Yes, r-HuEPO is also known as NeoRecormon, a brand name for recombinant human erythropoietin beta. The clinical trial NCT02767765 specifically refers to NeoRecormon, confirming that r-HuEPO and NeoRecormon are the same drug.