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Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients

NCT00711958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2017-09-05

Study results available
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Summary

This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged \>18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be included to provide a reference reflecting current standard medical practice.

Conditions

Interventions

DRUG

HX575, solution for injection (s.c.)

1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin

DRUG

ERYPO®, Janssen-Cilag, solution for injection (s.c.)

1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa

Sponsors & Collaborators

  • Hexal AG

    collaborator INDUSTRY

  • Sandoz

    lead INDUSTRY

Principal Investigators

  • Andrea Vetter, Dr. · Hexal AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-07-31
Completion
2005-12-31

Countries

  • Germany
  • Romania

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00711958 on ClinicalTrials.gov