Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Beta-thalassemia patients with documented non-compliance to deferoxamine, defined as taking less than 50% of prescribed doses in year prior to study, and having a liver iron content at least 14 mg iron/gm dry weight liver tissue
Beta-thalassemia patients unable to take deferoxamine because of documented side effects or contra-indication, or documented poor response despite proper compliance, with liver iron content at least 2 mg iron/gm dry weight liver tissue
Patients with chronic anemias with a liver iron content at least 2 mg/gm dry weight liver tissue.
Beta-thalassemia or other chronic anemia patients having previously taken deferiprone, provided that they stop the deferiprone at least 28 days before the study and have a liver iron content at least 2 mg/gm dry weight liver tissue.
All patients: Regular transfusions indicated by a requirement of at least 8 blood transfusions per year.
Life expectancy of at least one year.
You may not be if
Beta-thalassemia able to be treated with deferoxamine, Sickle Cell Disease or non-transfusional iron overload
Elevated liver enzymes in the year preceding enrollment
Active Hepatitis B or Hepatitis C
HIV seropositivity
Elevated serum creatinine or significant proteinuria
History of nephrotic syndrome
Uncontrolled systemic hypertension
Fever and other signs/symptoms of infection within 10 days prior to start of the study.
Presence of clinically relevant cataract or previous history of clinically relevant ocular toxicity related to iron chelation.
Second or third degree AV block, clinically relevant Q-T interval prolongation, or patients requiring digoxin or other drugs that prolong the Q-T interval.
Diseases (cardiovascular, renal, hepatic, etc.) that would prevent the patient from undergoing any of the treatment options.
Psychiatric or additive disorders that would prevent the patient from giving informed consent.
History of drug or alcohol abuse within the 12 months prior to the study.
Pregnant or breast feeding patients.
Patients treated with systemic investigational drugs within 4 weeks or topical investigational drugs within 7 days before the start of teh study.
Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as gastrointestinal disease or major surgery, renal disease, difficulty voiding or urinary obstruction, or impaired pancreatic function.
Non-compliant or unreliable patients
Patients unable to undergo any study procedures such as the hearing or eye tests, or the liver echocardiography.
Patients that would need a dose of Deferasirox less than 125 mg per day.
Clareo Health | Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias
