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:
NCT00144482
First received: September 2, 2005
Last updated: January 29, 2009
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in QOL scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

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: NCT00144482

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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144482     History of Changes
Other Study ID Numbers: EPO307JP
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 April 16, 2014