EUCTR2016-002529-12-BE
Active, not recruiting
Phase 1
A phase II, multicenter, open-label, randomized two-year study to evaluate the efficacy and safety of deferasirox film-coated tablet versus phlebotomy in patients with Hereditary Hemochromatosis
DrugsExjade
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma AG
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female \= 18\-years\-old
- •\- Documented genotype testing confirming homozygous for the C282Y mutation (C282Y/C282Y)
- •\- Transferrin saturation \= 45% (at either screening visit)
- •\- Serum Ferritin \= 500 µg/L (at either screening visit)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 120
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 30
Exclusion Criteria
- •1\. Medical conditions that preclude inclusion:
- •\- Iron overload not due to HH
- •\- Condition which might significantly alter the absorption, distribution,
- •metabolism or excretion of oral deferasirox
- •\- Systemic disease which prevents taking study treatment or any
- •contraindication to phlebotomy
- •\- Inflammatory condition or immunological disease which may interfere
- •with the SF interpretation, such as an active infection, collagen vascular
- •disorders, irritable bowel syndrome, lupus, or immune thrombocytopenia
- •\- Significantly impaired gastrointestinal function or disease that may
Outcomes
Primary Outcomes
Not specified
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