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

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Chemotherapy Induced Anemia

Treatments: Drug: recombinant human erythropoietin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144495

EPO308JP

Details and patient eligibility

About

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

Enrollment: 104 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cancer patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

104 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: recombinant human erythropoietin

Drug: recombinant human erythropoietin

2

Experimental group

Description:

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

Treatment:

Drug: recombinant human erythropoietin

Drug: recombinant human erythropoietin