NCT00495378

Brief Summary

The purpose of this study was to determine if alternate dosing of Epoetin alfa was effective in maintaining hemoglobin levels in patients with chemotherapy related anemia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_4

Status
terminated

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

November 1, 2002

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
Last Updated

December 20, 2016

Status Verified

June 1, 2007

First QC Date

June 29, 2007

Last Update Submit

December 19, 2016

Conditions

ChemotherapyCancerAnemia

Keywords

PROCRITEpoetin alfachemotherapy related anemia

Outcome Measures

Primary Outcomes (1)

  • Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.

Interventions

epoetin alfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chemotherapy related anemia
  • Patients with a diagnosis of malignancy
  • Patients with initial weekly PROCRIT (Epoetin alfa) therapy for at least 4 weeks
  • Patients must have received PROCRIT (Epoetin alfa) maintenance therapy with less frequent dosing (e.g. every 2 weeks, every 3 weeks, every 4 weeks) for at least 6 weeks immediately following once weekly dosing.

You may not qualify if:

  • No previous diagnosis of hemolytic anemia or myelodysplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

NeoplasmsAnemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Ortho Biotech Products, L.P. Clinical Trial

    Ortho Biotech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 3, 2007

Study Start

November 1, 2002

Study Completion

March 1, 2003

Last Updated

December 20, 2016

Record last verified: 2007-06