A Two-year Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis.
Active, not recruiting
Novartis Pharmaceuticals
Phase 2
2018-01-11
The purpose of this study is to evaluate the efficacy and safety of deferasirox film coated
tablet (FCT) versus phlebotomy for the management of iron overload in adults with HH at risk
of iron-related morbidity. This evaluation will provide information on the two treatment
options in terms of the rate of response of proportion of patients reaching the study target
SF ≤ 100 μg/L and their associated safety profiles.
In addition to exploring the safety and efficacy of deferasirox FCT in hereditary
hemochromatosis (HH), this study is being conducted to fulfill an FDA post-marketing
requirement [PMC 750-10 (Exjade) /PMR 2888-8 (Jadenu)] to provide additional randomized data
to confirm the ocular safety profile of deferasirox through detailed ocular assessments in
patients treated with deferasirox FCT for 2 years.
Pilot Study to Assess the Safety, PK and Iron Chelating Activity of DST-0509 (Deferasirox) in Thalassemia Patients Refractory to Chelation
Recruiting
DisperSol Technologies, LLC
Phase 2
2019-08-20
This study is a multicenter, open-label, two-period crossover design that evaluates the
safety, tolerability, pharmacokinetics and preliminary evidence of iron chelating activity of
DST-0509 as compared to Jadenu and Exjade in transfusion-dependent thalassemia patients with
transfusional iron overload, requiring iron chelation therapy and demonstrating an inadequate
response to Jadenu or Exjade for greater than 3 months duration. Up to 36 patients will be
evaluated (18 in each treatment arm), however, the balanced randomization may enroll fewer
patients based on recruitment status.
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