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Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study

NCT00940602 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2020-11-23

Study results available
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Summary

This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.

Conditions

Interventions

DRUG

Deferasirox

Deferasirox provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use

DRUG

Placebo

Inactive ingredients used as a placebo comparator, provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-22
Primary Completion
2018-02-27
Completion
2018-02-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • China
  • Denmark
  • Greece
  • Hong Kong
  • Italy
  • Malaysia
  • Mexico
  • New Zealand
  • Russia
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00940602 on ClinicalTrials.gov