Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-09-30

Brief Summary

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This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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EPOCH

Group Type EXPERIMENTAL

epoetin beta

Intervention Type DRUG

Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subcutaneous administration of placebo once-weekly for 12 weeks

Interventions

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epoetin beta

Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks

Intervention Type DRUG

placebo

Subcutaneous administration of placebo once-weekly for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Lung cancer or gynecologic cancer patients
* Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
* 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
* 20 - 79 years old
* Performance status: 0 - 2
* No iron deficiency anemia