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HX575 epoetin alfa Hexal AG · 1 trial · 1 indication
Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (\<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval \[-0.5 g/dL; 0.5 g/dL\]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population.
| Arm | Type | Description |
|---|---|---|
| HX575 epoetin alfa Hexal AG | EXPERIMENTAL | Eligible patients were switched from the comparator ERYPO®, to epoetin alfa HX575 Hexal AG in ratio 2:1 to be intravenously treated with HX575 in pre-filled syringes for 24 weeks (solution for injection i.v.). The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. |
| ERYPO®, Janssen-Cilag | ACTIVE_COMPARATOR | Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. |
| Name | Type | Description |
|---|---|---|
| HX575 epoetin alfa Hexal AG | DRUG | HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin |
| ERYPO®, Janssen-Cilag | DRUG | Solution for i.v. injection |
Inclusion Criteria: * Receiving dialysis for at least 6 months (3 times weekly) before screening * Age: \>=18 * Clinically stable, i.e. hemoglobin within the established range (10.0 to 13.0 g/dl) for at least 12 weeks before screening * Stable intravenous dosage of ERYPO® three times weekly for at ...
HX575 epoetin alfa Hexal AG is an investigational drug being developed for the treatment of anemia. It is a small molecule being studied in a Phase 3 clinical trial for anemia in hemodialysis patients. The drug is not yet approved and remains in clinical development.
HX575 epoetin alfa Hexal AG is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 3 clinical development for the treatment of anemia.
HX575 epoetin alfa Hexal AG is in Phase 3 clinical development. It is an investigational drug for anemia and has not been approved. One Phase 3 trial has been completed, with a total enrollment of 478 participants.
HX575 epoetin alfa Hexal AG has one completed Phase 3 trial, NCT00666835, which evaluated its efficacy and safety versus ERYPO for anemia in hemodialysis patients. The trial enrolled 478 participants in Austria and Germany and was randomized, double-blind, and active-controlled.
HX575 epoetin alfa Hexal AG is a form of epoetin alfa, as indicated by its name. It is being studied as a potential treatment for anemia, with a completed Phase 3 trial comparing it to ERYPO, another epoetin alfa product.