Health Condition 1: D599- Acquired hemolytic anemia, unspecified
Conditions
Interventions
Intervention1: Lonexa, Solution for Injections: Pre-filled syringes containing 0.4 ml of solution
Control Intervention1: Aranesp, Solution for Injection: 1 pre-filled syringe Darbepoetin alfa (recombi
Sponsors
PSK Pharma LLC
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1 Presence of chemotherapy-induced anemia (at least 1 course of chemotherapy was conducted before screening). 2 Scheduled chemotherapy within 12 weeks after randomization. The expected duration of chemotherapy after the first administration of the study/reference product should be NLT 12 weeks/NLT 3 courses of chemotherapy. 3 Hemoglobin concentration >= 80 and 4 Sufficient iron reserve (serum ferritin >= 100 µg/ml and transferrin saturation >= 20%) at the time of randomization. 5 Consent of the patient to use reliable methods of contraception throughout the study and within 3 weeks after its completion;
Exclusion criteria
Exclusion criteria: 1 Difficulties or inability to perform subcutaneous and intravenous injections. 2 Established hypersensitivity to rhuEPO or any of the components of the study/reference product, including latex allergy (needle cap in syringes of the study/reference product contains latex, which can cause allergic reactions in latex-sensitive people), as well as iron (III) hydroxide saccharose complex or iron preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with increase in hemoglobin concentration â?¥ 20 g/lTimepoint: by 12th week of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamics in hemoglobin concentration Timepoint: during 12 weeks of therapy.;Number of patients who needed RBC transfusion Timepoint: during 12 weeks of therapy.;Number of patients with increase in hemoglobin concentration â?¥ 10 g/l 20 g/lTimepoint: by 12th week of therapy. | — |
Countries
India
Contacts
Public ContactDr S Sadgune
Mudra Clincare
Outcome results
None listed