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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:
NCT00144495
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
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label 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: Day 28th or later ]

Secondary Outcome Measures:
  • Changes in QOL scores [ Time Frame: 84 days ]

Enrollment: 104
Study Start Date: February 2004
Study Completion Date: May 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patient whose ΔHb is less than 1.0g/dL on the day of 7th administration
Drug: recombinant human erythropoietin
3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
Experimental: 2
patient whose ΔHb is 1.0g/dL or above on the day of 7th administration
Drug: recombinant human erythropoietin
36000IU(s.c.)/week for 12 weeks

  Eligibility

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:

  • 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): NCT00144495


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

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144495     History of Changes
Other Study ID Numbers: EPO308JP
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