A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144482

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 III

MedlinePlus related topics: Cancer

Drug Information available for: Epoetin alfa Erythropoietin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

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
1: Experimental	Drug: recombinant human erythropoietin 36000IU（0.5mL）s.c./week for 8 weeks
2: Placebo Comparator	Drug: recombinant human erythropoietin placebo 0 IU(0.5mL)s.c./week for 8 weeks

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	EPO307JP
Study First Received:	September 2, 2005
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00144482
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Epoetin Alfa
Anemia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009