Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients
Phase 1
Active, not recruiting
- Conditions
- Sickle Cell Disease/ Iron OverloadTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2016-002583-14-Outside-EU/EEA
- Lead Sponsor
- ovartis Pharmaceuticals Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
•Age greater than or equal to 2 years
•Male or female patients with sickle cell disease (SS, SC, SD, Sßo or Sß+ thalassemia)
•Iron overload from repeated blood transfusion
Are the trial subjects under 18? yes
Number of subjects for this age range: 203
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 77
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Serum creatinine above the upper limit of normal
•Significant proteinuria•History of nephrotic syndrome
•Alanine aminotransferase (ALT) = 250 U/L at screening
•Clinical evidence of active hepatitis B or hepatitis C
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety of ICL670 compared to deferoxamine during 24 weeks in patients with sickle cell disease and iron overload from repeated blood transfusions;Secondary Objective: Long term safety of ICL670 for up to 104 weeks in patients with sickle cell disease and iron overload from repeated blood transfusions;Primary end point(s): -The Number of Participants with Adverse Events (AEs) in the First 24 Weeks of Treatment<br>-The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks;Timepoint(s) of evaluation of this end point: -24 weeks<br>-24 weeks
- Secondary Outcome Measures
Name Time Method