Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00711958 | Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients | PHASE3 | COMPLETED | 114 | — | — | Nov 1, 2004 | Dec 1, 2005 | Sep 5, 2017 | 19 | Germany, Romania |
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...