CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 114 enrolled
Drug / intervention
HX575, solution for injection (s.c.) +1 moredrug
Likely dose
HX575, solution for injection (s.c.) 10.000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00711958
NCT00711958Phase 3Completed
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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

Sandoz·interventional·Posted Jul 9, 2008·Updated Sep 5, 2017

In Brief

A Phase 3 clinical trial evaluating HX575, solution for injection (s.c.) and ERYPO®, Janssen-Cilag, solution for injection (s.c.) for Anemia. Completed, enrolled 114 participants across 19 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesGermany, Romania
CollaboratorsHexal AG

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2008
Enrollment StartNov 1, 2004
Primary CompletionJul 1, 2005
Study CompletionDec 1, 2005
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.0 years ago

Interventions

HX575, solution for injection (s.c.)drug

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

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

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