Efficacy and safety of Darbepoetin alfa, solution for injections for treatment of anemia in patients with non-myeloid malignant neoplasms receiving chemotherapy
- Conditions
- Health Condition 1: D599- Acquired hemolytic anemia, unspecified
- Registration Number
- CTRI/2020/09/027840
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <= 100 g/l at the time of randomization.
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;
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients with increase in hemoglobin concentration â?¥ 20 g/lTimepoint: by 12th week of therapy.
- Secondary Outcome Measures
Name Time Method Dynamics in hemoglobin concentration <br/ ><br>Timepoint: during 12 weeks of therapy.;Number of patients who needed RBC transfusion <br/ ><br>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.