Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628043

Enrollment

160

Registered

2008-03-04

Start date

2008-05-31

Completion date

2009-09-30

Last updated

2009-09-18

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

Conditions

Anemia

Keywords

Cancer, patients, with, chemotherapy, induced, anemia

Brief summary

This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.

Interventions

DRUGepoetin beta

Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks

DRUGplacebo

Subcutaneous administration of placebo once-weekly for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Lung cancer or gynecologic cancer patients * Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration * 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL * 20 - 79 years old * Performance status: 0 - 2 * No iron deficiency anemia

Exclusion criteria

* Red blood cell transfusion within 4 weeks before treatment * Erythropoietin therapy within 8 weeks before treatment

Design outcomes

Primary

Measure	Time frame
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL	16 weeks

Secondary

Measure	Time frame
Change in FACT- total Fatigue Subscale score (FSS)	16 weeks
Requirement for RBC transfusion	16 weeks
Change in Hb	16 weeks

Countries

Japan

Outcome results

None listed

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