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Completed

NCT Number: NCT00628043

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chugoku/Shikoku Region, Chugoku/Shikoku, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin beta

Drug

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

Placebo

Drug

Subcutaneous administration of placebo once-weekly for 12 weeks

Primary outcomes

  1. The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL

    Time frame: 16 weeks

Secondary outcomes

  1. Change in Hb

    Time frame: 16 weeks

  2. Change in FACT- total Fatigue Subscale score (FSS)

    Time frame: 16 weeks

  3. Requirement for RBC transfusion

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 4, 2008
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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