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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144495
First received: September 2, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Anemia Cancer
U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • The increase in Hb concentration [ Time Frame: Day 28th or later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in QOL scores [ Time Frame: 84 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144495

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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144495     History of Changes
Other Study ID Numbers: EPO308JP
Study First Received: September 2, 2005
Last Updated: January 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013