NCT00711958

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Anemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-07-01
• Completion: 2005-12-01
• First posted: 2008-07-09
• Last updated: 2017-09-05
• Results posted: 2017-08-02

Locations

19 sites across 2 countries: Germany, Romania