Cost-effectiveness Study of Epoetin Alfa and Darbepoetin Alfa in Adult Patients With Cancer Who Have Anemia
|ClinicalTrials.gov Identifier: NCT00264108|
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : May 7, 2014
|Condition or disease||Intervention/treatment|
|Anemia Neoplasms||Drug: Darbepoetin alfa Drug: Epoetin alfa|
|Study Type :||Observational|
|Actual Enrollment :||492 participants|
|Official Title:||EPREX (Epoetin Alfa) Versus ARANESP (Darbepoetin Alfa): Looking at Outcome of Anemia Treatment and Comparing Cost-effectiveness (EVALUATE).|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Epoetin alfa 40 000 IU once weekly variable treatment length.
Drug: Epoetin alfa
40,000 IU once weekly, variable treatment length.
Darbepoetin alfa Either 150 ug once weekly or 500 ug once every 3 wks variable treatment length.
Drug: Darbepoetin alfa
Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.
- Cost-effectiveness based on: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin alfa, use of blood transfusions, serum iron levels and iron supplementation. [ Time Frame: 4 weeks, 8 weeks and end of treatment ]
- Safety evaluations including the incidence of serious and non-serious adverse events. [ Time Frame: from start of (Darb)epoetin treatment to end of study. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264108
|Bergen Op Zoom, Netherlands|
|Den Helder, Netherlands|
|Ede Gld, Netherlands|
|Study Director:||Janssen-Cilag B.V. Clinical Trial||Janssen-Cilag B.V.|