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A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00144482
Enrollment
122
Registered
2005-09-05
Start date
2003-12-31
Completion date
2005-08-31
Last updated
2009-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Induced Anemia

Brief summary

To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy

Interventions

DRUGrecombinant human erythropoietin

36000IU(0.5mL)s.c./week for 8 weeks

DRUGrecombinant human erythropoietin placebo

0 IU(0.5mL)s.c./week for 8 weeks

Sponsors

Chugai Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Cancer patients

Exclusion criteria

* a history of myocardial, cerebral or pulmonary infarction * severe hypertension beyond control by drugs

Design outcomes

Primary

MeasureTime frame
The increase in Hb concentrationweek 8

Secondary

MeasureTime frame
Changes in QOL scores8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026