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

Chemotherapy Induced Anemia Clinical Trial

Official title:

A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144482
• Other study ID #: EPO307JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: January 29, 2009
• Start date: December 2003
• Est. completion date: August 2005

Study information

• Verified date: January 2009
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• Cancer patients

Exclusion Criteria:

• a history of myocardial, cerebral or pulmonary infarction

• severe hypertension beyond control by drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Induced Anemia

Intervention

Drug:
• recombinant human erythropoietin
36000IU(0.5mL)s.c./week for 8 weeks
• recombinant human erythropoietin placebo
0 IU(0.5mL)s.c./week for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The increase in Hb concentration		week 8	No
Secondary	Changes in QOL scores		8 weeks	No