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

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ClinicalTrials.gov Identifier: NCT00144482
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : February 2, 2009
Sponsor:
Information provided by:
Chugai Pharmaceutical

Brief Summary:
To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Anemia Drug: recombinant human erythropoietin Drug: recombinant human erythropoietin placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
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
Study Start Date : December 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
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

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

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

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics