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A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00144482
First Posted: September 5, 2005
Last Update Posted: February 2, 2009
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.
Information provided by:
Chugai Pharmaceutical
  Purpose
To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy

Condition Intervention Phase
Chemotherapy Induced Anemia Drug: recombinant human erythropoietin Drug: recombinant human erythropoietin placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • The increase in Hb concentration [ Time Frame: week 8 ]

Secondary Outcome Measures:
  • Changes in QOL scores [ Time Frame: 8 weeks ]

Enrollment: 122
Study Start Date: December 2003
Study Completion Date: August 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: recombinant human erythropoietin
36000IU(0.5mL)s.c./week for 8 weeks
Placebo Comparator: 2 Drug: recombinant human erythropoietin placebo
0 IU(0.5mL)s.c./week for 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer patients

Exclusion Criteria:

  • a history of myocardial, cerebral or pulmonary infarction
  • severe hypertension beyond control by drugs
  Contacts and Locations
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): NCT00144482


Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Yoshiharu Ishikura Chugai Pharmaceutical
  More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144482     History of Changes
Other Study ID Numbers: EPO307JP
First Submitted: September 2, 2005
First Posted: September 5, 2005
Last Update Posted: February 2, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics