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

NCT ID: NCT00144495

Last Updated: 2009-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-05-31

Brief Summary

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

Detailed Description

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Conditions

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Chemotherapy Induced Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

patient whose ΔHb is less than 1.0g/dL on the day of 7th administration

Group Type EXPERIMENTAL

recombinant human erythropoietin

Intervention Type DRUG

3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks

2

patient whose ΔHb is 1.0g/dL or above on the day of 7th administration

Group Type EXPERIMENTAL

recombinant human erythropoietin

Intervention Type DRUG

36000IU(s.c.)/week for 12 weeks

Interventions

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recombinant human erythropoietin

3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks

Intervention Type DRUG

recombinant human erythropoietin

36000IU(s.c.)/week for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cancer patients

Exclusion Criteria

* a history of myocardial, cerebral or pulmonary infarction
* severe hypertension beyond control by drugs
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Chugai Pharmaceutical

Principal Investigators

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Yoshiharu Ishikura

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Other Identifiers

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EPO308JP

Identifier Type: -

Identifier Source: org_study_id

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