Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HX575 · 1 trial · 1 indication
Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.
| Arm | Type | Description |
|---|---|---|
| HX575 epoetin alfa Hexal AG | EXPERIMENTAL | HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. |
| ERYPO® Janssen-Cilag | ACTIVE_COMPARATOR | ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * Patients with a confirmed diagnosis of solid tumors * Patients who receive cyclic palliative chemotherapy with a cycle duration of 1 -4 weeks (for at least 12 weeks) during the study * Patients with chemotherapy associated anemia (hemoglobin \< 10.0 g/dl at screening) * Life e...
HX575 is an investigational small molecule being developed for the treatment of anemia. It is being studied in the context of chemotherapy-associated anemia in cancer patients. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
HX575 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the efficacy and safety of HX575 in patients with anemia.
HX575 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 3 trial for HX575 has been completed, and the drug is being evaluated for the treatment of chemotherapy-associated anemia in cancer patients.
HX575 has one completed Phase 3 clinical trial registered under NCT00711958. The trial, titled 'Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients,' enrolled 114 participants in Germany and Romania. The study was randomized, double-blind, and active-controlled.
HX575 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed Phase 3 trial assessed its efficacy and safety in treating chemotherapy-associated anemia, but regulatory approval has not been granted. The drug remains under investigation by Novartis.