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A phase III randomized double-blind placebo-controlled study of epoetin beta for the treatment of chemotherapy-induced anemia in cancer patients

A phase III randomized double-blind placebo-controlled study of epoetin beta for the treatment of chemotherapy-induced anemia in cancer patients

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220560
Enrollment
Unknown
Registered
2008-05-26
Start date
2008-05-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Chemotherapy-induced anemia

Interventions

investigational material(s) Generic name etc : Recombinant human erythropoietin INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone pre

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Lung cancer or gynecologic cancer - Underwent platinum-based chemotherapy repeated for >= 2 cycles after 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 - No red blood cell transfusion within 4 weeks before treatment - No erythropoetin therapy within 8 weeks before treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Primary endpoint The proportion of the subjects who receive RBC transfusion and/or Hb concentration < 8.0 g/dL Secondary endpoints - Change in Hb - Change in FACT-An total Fatigue subscale score (FSS) - Requirement for RBC transfusion—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026