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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

Tracking Information
First Submitted Date  ICMJE February 24, 2008
First Posted Date  ICMJE March 4, 2008
Last Update Posted Date September 18, 2009
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
The proportion of the subjects who receive RBC transfusion and/or Hb concentration < 8.0 g/dL [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
  • Change in Hb [ Time Frame: 16 weeks ]
  • Change in FACT- total Fatigue Subscale score (FSS) [ Time Frame: 16 weeks ]
  • Requirement for RBC transfusion [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
  • Change in Hb [ Time Frame: 16 weeks ]
  • Change in FACT-An total Fatigue subscale score (FSS) [ Time Frame: 16 weeks ]
  • Requirement for RBC transfusion [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
Official Title  ICMJE A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE
  • Drug: epoetin beta
    Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
  • Drug: placebo
    Subcutaneous administration of placebo once-weekly for 12 weeks
Study Arms  ICMJE
  • Experimental: EPOCH
    Intervention: Drug: epoetin beta
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 3, 2008)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00628043
Other Study ID Numbers  ICMJE EPO316 JP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chugai Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Chugai Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yoshito Suzuki Chugai Pharmaceutical
PRS Account Chugai Pharmaceutical
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP