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

Anemia Clinical Trial

Official title: Double-blind, Randomized, Multicenter, Clinical Phase III Study to Evaluate the Efficacy and Safety of HX575 for the Treatment of Chemotherapy Associated Anemia in Cancer Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

Eligible patients were randomized to one of two different treatment groups (EPO HEXAL or ERYPO) in a 2:1 ratio. Patients received double-blind treatment for a period of 12 weeks. Following randomization the patients were treated subcutaneously with a dose of 150 IU/kg body weight of study drug three times per week. Dose adjustments to 300 IU/kg body weight three times per week were to be done if hemoglobin (Hb) increased <1.0 g/dL or the reticulocyte count increased <40,000 /μl after 4 weeks or if Hb increased <2.0 g/dL after 8 weeks of treatment. The primary endpoint was the Hb response in the EPO HEXAL group during weeks 5-12 of the study defined as absolute increase in Hb value of 2.0 g/dL from the mean value of the screening/baseline period in the absence of red blood cell transfusion during the preceding 4 weeks. For that purpose, Hb levels were measured at the weekly study visits by a central laboratory. Further parameters of treatment efficacy, safety and tolerability were recorded. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT00711958
• Study type: Interventional
• Source: Sandoz
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Completion date: December 2005