Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment

Hoffmann-La Roche0 sites10 target enrollmentApril 2006

ConditionsAnemia

InterventionsEpoetin Beta

DrugsEpoetin Beta

Overview

Phase: Phase 4
Intervention: Epoetin Beta
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Enrollment: 10
Primary Endpoint: Hemoglobin Levels at 16 Weeks
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

December 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients with a non-myeloid malignancy

Exclusion Criteria

•Transfusion of red blood cells within 2 months of study drug
•Treatment-resistant hypertension
•Acute or chronic bleeding (requiring therapy) within 3 months of study drug

Arms & Interventions

Epoetin Beta 30000 IU

Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks.

Intervention: Epoetin Beta

Outcomes

Primary Outcomes

Hemoglobin Levels at 16 Weeks

Time Frame: 16 Weeks

Secondary Outcomes

Serum Iron Levels(16 Weeks)
Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument(Up to 4 months)
Tolerability - Incidence of Adverse Events(Up to 4 months)
Serum Transferrin Levels(16 Weeks)
Percentage of Participants With A Positive Response(16 Weeks)
Time To Global Response(Up to 4 months)
Quality of Life In Relation to Anemia Grade(Up to 4 months)
Serum Ferritin Levels(16 Weeks)