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

Phase 3

Completed

• Conditions: Chemotherapy Induced Anemia
• Interventions: Drug: recombinant human erythropoietin

• Registration Number: NCT00144495
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-11
• Study Completion: 2005-05
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-29
• Last Update Posted: 2009-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Cancer patients

Exclusion Criteria

• a history of myocardial, cerebral or pulmonary infarction
• severe hypertension beyond control by drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	recombinant human erythropoietin	patient whose ΔHb is less than 1.0g/dL on the day of 7th administration
2	recombinant human erythropoietin	patient whose ΔHb is 1.0g/dL or above on the day of 7th administration

Primary Outcome Measures

Name	Time	Method
The increase in Hb concentration	Day 28th or later

Secondary Outcome Measures

Name	Time	Method
Changes in QOL scores	84 days