EUCTR2016-002529-12-ES
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
ovartis Farmacéutica, S.A.0 sites150 target enrollmentAugust 2, 2017
ConditionsHereditary HemochromatosisMedDRA version: 20.0Level: LLTClassification code 10057874Term: Hereditary hemochromatosisSystem Organ Class: 100000012236Therapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsExjade
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hereditary Hemochromatosis
- Sponsor
- ovartis Farmacéutica, S.A.
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 8 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 \= 700 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 significantly alter the absorption of oral deferasirox, e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption
- •2\. Prior iron chelation therapy, prohibited concomitant medications with deferasirox
- •syndrome, or small bowel resection.
- •\- Psychiatric or addictive disorder which prevent giving informed consent or undergoing any of the treatment options or unwilling or unable to comply with the protocol
- •\- Uncontrolled or significant cardiac disease or symptomatic cardiac arrhythmias, e.g., sustained ventricular tachycardia and clinically significant second or third degree AV block without a pacemaker
Outcomes
Primary Outcomes
Not specified
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