NCT00144495

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

February 2, 2009

Status Verified

January 1, 2009

Enrollment Period

9 months

First QC Date

September 2, 2005

Last Update Submit

January 29, 2009

Conditions

Chemotherapy Induced Anemia

Outcome Measures

Primary Outcomes (1)

  • The increase in Hb concentration

    Day 28th or later

Secondary Outcomes (1)

  • Changes in QOL scores

    84 days

Study Arms (2)

1

EXPERIMENTAL

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

Drug: recombinant human erythropoietin

2

EXPERIMENTAL

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

Drug: recombinant human erythropoietin

Interventions

recombinant human erythropoietinDRUG

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

1

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yoshiharu Ishikura

    Chugai Pharmaceutical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

February 1, 2004

Primary Completion

November 1, 2004

Study Completion

May 1, 2005

Last Updated

February 2, 2009

Record last verified: 2009-01