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CompletedNCT00144482Updated Feb 2, 2009

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

A Phase 3 interventional study of recombinant human erythropoietin and recombinant human erythropoietin placebo in Chemotherapy Induced Anemia, sponsored by Chugai Pharmaceutical. Completed. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2009-02-02.

Sponsored by Chugai Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Chemotherapy Induced Anemia
03

In context

Lead sponsor

Chugai Pharmaceutical is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cancer patients

Exclusion criteria

Exclusion Criteria:

  • a history of myocardial, cerebral or pulmonary infarction
  • severe hypertension beyond control by drugs
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    1

    Drug: recombinant human erythropoietin

  • Placebo comparator
    2

    Drug: recombinant human erythropoietin placebo

Interventions

  • Drugrecombinant human erythropoietin

    36000IU(0.5mL)s.c./week for 8 weeks

  • Drugrecombinant human erythropoietin placebo

    0 IU(0.5mL)s.c./week for 8 weeks

06

What researchers measure

Primary outcomes

  1. The increase in Hb concentration

    Time frame: week 8

Secondary outcomes

  1. Changes in QOL scores

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00144482
Lead sponsor
Chugai Pharmaceutical
First posted
Sep 5, 2005
Start date
Dec 2003
Primary completion
Mar 2005
Completion
Aug 2005
Last update
Feb 2, 2009

Study contacts

Yoshiharu Ishikura
study director · Chugai Pharmaceutical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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