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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00628043
First received: February 24, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: epoetin beta
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Hb [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in FACT- total Fatigue Subscale score (FSS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Requirement for RBC transfusion [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPOCH Drug: epoetin beta
Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
Placebo Comparator: placebo Drug: placebo
Subcutaneous administration of placebo once-weekly for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628043

Locations
Japan
Chubu Region
Chubu, Japan
Chugoku/Shikoku Region
Chugoku/Shikoku, Japan
Hokkaido/Tohoku Region
Hokkaido/Tohoku, Japan
Kanto/Koshinetsu Region
Kanto/Koshinetsu, Japan
Kinki/Hokuriku Region
Kinki/Hokuriku, Japan
Kyushu Region
Kyushu, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Chair: Yoshito Suzuki Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00628043     History of Changes
Other Study ID Numbers: EPO316 JP
Study First Received: February 24, 2008
Last Updated: September 17, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Chugai Pharmaceutical:
Cancer
patients
with
chemotherapy
induced
anemia

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014