Clinical Trials Directory

Trials / Completed

CompletedNCT01335035

Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT). The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving \> 20 RBC concentrates) after allogeneic HSCT.

Conditions

Interventions

TypeNameDescription
DRUGdeferasirox

Timeline

Start date
2008-12-01
Primary completion
2011-05-01
First posted
2011-04-13
Last updated
2012-05-01

Locations

9 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT01335035. Inclusion in this directory is not an endorsement.