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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014