ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00628043
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Chugai Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: epoetin beta Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chugai Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00628043     History of Changes
Other Study ID Numbers: EPO316 JP
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics