Overview

An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
Summary
This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- Adults greater than or equal to (≥) 18 years of age

- Participants with solid tumors or lymphoproliferative disease

- Participants receiving chemotherapy

- Participants for whom erythropoietin is indicated for pre-study Hb level and observed
anemic symptoms: Hb less than (<) 11 g/dL or 6.83 millimoles per liter (mmol/L)

- ECOG performance status of 0, 1, or 2

Exclusion Criteria:

- Resistant hypertension

- Acute chronic bleeding within 3 months prior to study

- Iron deficiency that is unmanageable prior to study

- Hypersensitivity to the active substance or any of the excipients of the product

- Pregnant or breastfeeding women

- Epoetin treatment within 6 months prior to study