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A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy

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Roche

Status and phase

Completed
Phase 3

Conditions

Anemia

Treatments

Drug: r-HuEPO

Study type

Interventional

Funder types

Industry

Identifiers

NCT02767765
ML17435

Details and patient eligibility

About

This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 hypersensitivity to active or inactive excipients of r-HuEPO
  • Insufficient controllable hypertension
  • Thalassemic syndromes
  • Anemia caused by hematic loss
  • Women who are pregnant or lactating

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

r-HuEPO
Experimental group
Description:
Anemic cancer participants will receive r-HuEPO for 4 weeks.
Treatment:
Drug: r-HuEPO

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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