Trials / Completed
CompletedNCT01709838
Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia
An Open Label, Multi-center, Efficacy and Safety Study of Deferasirox in Iron Overloaded Patients With Non-transfusion Dependent Thalassemia
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
Summary
Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | deferasirox | Deferasirox dispersible tablets at strengths of 125 mg, 250 mg, and 500 mg were administered by oral daily dosing. |
Timeline
- Start date
- 2012-12-06
- Primary completion
- 2015-01-03
- Completion
- 2019-01-17
- First posted
- 2012-10-18
- Last updated
- 2019-10-02
- Results posted
- 2019-08-28
Locations
11 sites across 8 countries: China, Greece, Italy, Lebanon, Thailand, Tunisia, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01709838. Inclusion in this directory is not an endorsement.