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Effect of Deferiprone on Oxidative-Stress and Iron-Overload in Low Risk Transfusion-Dependent MDS Patients

NCT02477631 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-11-01

No results posted yet for this study

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.

Conditions

  • Myelodysplastic Syndrome With Low-grade Lesions
  • Iron Overload Due to Repeated Red Blood Cell Transfusions

Interventions

DRUG

Deferiprone

This is a single-arm, open-label, multi-center study in 20 patients with MDS. All participants will be treated with deferiprone for up to 4 months.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Tel Aviv Medical Center

    collaborator OTHER

  • Kaplan Medical Center

    collaborator OTHER

  • Ziv Medical Center

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Drorit Merkel, MD · Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-05-31
Completion
2018-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477631 on ClinicalTrials.gov