Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-28 @ 1:54 AM
Study NCT ID:
NCT00711958
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2008-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients
Sponsor:
Sandoz
Organization:
Study Overview
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
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: