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
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, see Learn About Clinical Studies.

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:
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014