Anemia in patients with myelodysplastic syndrome. MedDRA version: 6.1 Level: PT Classification code 10038269
Conditions
Interventions
Trade Name: NESP
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA OSPEDALIERA BIANCHI-MELACRINO-MORELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Low or Intermediate-1 risk MDS. Hemoglobin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Secondary MDS or evolving from prior hematological malignancy. Intermediate-2 or High risk MDS. Uncontrolled hypertension (systolic blood pressure > 170 mmHg, diastolic blood pressure > 100 mmHg). Angina, uncontrolled arrythmia or heart failure. Previous thrombo-embolic events. Untreated thrombophilic abnormalities. Known hypersensitivity to rHuEPO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of the Darbepoetin alfa in patients with myelodysplastic syndromes (MDS). To evaluate the efficacy in terms of response (response / no response) of Darbepoetin alfa for the treatment of anemia in patients with MDS.;Secondary Objective: To evaluate the variations of hemoglobin and of the number of monthly transfusions during the course of treatment. To evaluate the changes of quality of life in the patients undergoing treatment.;Primary end point(s): Level of blood pressure, heart rate and number of adverse events (in terms of relative frequency). Number and type of responses to the treatment of anemia in patients with MDS. | — |
Countries
Italy
Outcome results
None listed