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

Phase 3

Completed

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

• Registration Number: NCT00144482
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2005-03
• Study Completion: 2005-08
• 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: 122

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	recombinant human erythropoietin	-
2	recombinant human erythropoietin placebo	-

Primary Outcome Measures

Name	Time	Method
The increase in Hb concentration	week 8

Secondary Outcome Measures

Name	Time	Method
Changes in QOL scores	8 weeks