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Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia

NCT01374373 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-07

No results posted yet for this study

Summary

The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin \< 10g/dl) undergoing palliative care chemotherapy.

Conditions

  • Antineoplastic Chemotherapy Induced Anemia

Interventions

BIOLOGICAL

Epoetin alfa

Epoetin alfa 40.000-60.000 IU/week subcutaneously that will be controlled and up or down titrated every 2 weeks according to the currently approved prescription guidance for a total of 12 weeks of treatment with Co administration of oral ferrous sulfate 200mg BID and oral folic acid 5mg QD

Sponsors & Collaborators

  • IC RESEARCH GROUP

    collaborator UNKNOWN

  • Bio Sidus SA

    lead INDUSTRY

Principal Investigators

  • Roberto Diez, MD · Bio Sidus SA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374373 on ClinicalTrials.gov