Effect of Deferiprone on Oxidative-Stress and Iron-Overload in Low Risk Transfusion-Dependent MDS Patients
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
The effect oral iron chelator Deferiprone on the Oxidative stress and on Iron Overload status
in transfusion dependent, iron-overloaded low risk MDS patients;
Primary Objective:
• To evaluate the effect of Deferiprone on oxidative stress parameter - Reactive oxygen
species (ROS).
Secondary Objectives:
- To evaluate the effect of Deferiprone on other oxidative stress parameters
1. Reduced glutathione
2. Membrane lipid peroxidation
3. External phosphatidylserine
- To evaluate the change from baseline to last visit in parameters of iron load.
1. Serum ferritin (despite ongoing RBC transfusions during the study period).
2. LIP
3. LPI
4. serum hepcidin
- To evaluate the change from one month preceding baseline visit to last month on study in
transfusion requirements.
- To monitor safety measures:
1. Adverse events (AEs).
2. Number of discontinuations due to AEs
Study design:
Single-arm, open-label, multi-center study in 20 iron-overloaded patients with low risk MDS.
All participants will be treated with deferiprone for up to 4 months. Patients will have
complete blood count monitored weekly, and will visit the site monthly for assessments of
safety and efficacy.
Phase:
Phase 2
Details
Lead Sponsor:
Sheba Medical Center
Collaborators:
Hadassah Medical Organization Kaplan Medical Center Tel Aviv Medical Center Ziv Medical Center