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Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases

NCT00115349 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-03-01

Study results available
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Summary

The purpose of this study is to determine whether left ventricular function improves more rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims include evaluating changes in myocardial iron burden using T2\* and estimating the relative incidence and severity of chelator-induced toxicity.

Conditions

Interventions

DRUG

Deferoxamine

Deferoxamine will be given daily for 12-24h/day 7 days a week either subcutaneous or intravenous at up to 50-60 mg/kg/day.

DRUG

Deferiprone (L1)

The dose of L1, 75mg/kg in three divided oral doses, is the maximum dose at which toxicity has been tested in prospective trials

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Carelon Research

    lead OTHER

Principal Investigators

  • John Porter, MD · University College, London

  • Patricia J. Giardina, MD · Weill Medical College of Cornell University

  • Ellis J. Neufeld, MD · Boston Children's Hospital

  • Elliott P, Vichinsky, MD · Children's Hospital and Research Institute, Oakland

  • Sonja McKinlay, Ph.D. · New England Research Institutes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-07-31
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00115349 on ClinicalTrials.gov