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

Chemotherapy Induced Anemia Clinical Trial

Official title:

A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144495
• Other study ID #: EPO308JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: January 29, 2009
• Start date: February 2004
• Est. completion date: May 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

The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2005
• Est. primary completion date: November 2004
• 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Induced Anemia

Intervention

Drug:
• recombinant human erythropoietin
3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
• recombinant human erythropoietin
36000IU(s.c.)/week for 12 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		Day 28th or later	No
Secondary	Changes in QOL scores		84 days	No