Evaluation of the Efficacy of Darbepoetin Alfa for the Treatment of Anemia in Patients with Myelodysplastic Syndrome - DARB-MDS
- Conditions
- Anemia in patients with myelodysplastic syndrome.MedDRA version: 6.1Level: PTClassification code 10038269
- Registration Number
- EUCTR2005-004737-17-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA BIANCHI-MELACRINO-MORELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 54
Low or Intermediate-1 risk MDS. Hemoglobin < 11.0 g/dL. No other evidence of causes of anemia. Adequate hepatic and renal function. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method