DEFERASIROX GASTROINTESTINAL TOLERABILITY STUDY
- Conditions
- transfusional haemosiderosisMedDRA version: 14.1Level: PTClassification code 10019024Term: HaemosiderosisSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2010-023217-61-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
Adults 18 years and over Ability to provide informed consent Ability to meet all study requirements Adequate renal function (e.g. creatinine clearance= 60ml/min), Wllingness to stop other iron chelation therapy, No known allergies to the drug Not pregnant or breast feeding and willing to use effective contraception For non-naive cohort: male or female participants with transfusional iron overload as defined by a minimum of 20 lifetime transfusion episodes and transfusional iron loading with ferritin levels >500 mcg/L and/or liver iron concentration >3 mg of iron/g dry weight (as previously demonstrated by liver biopsy or MRI prior to the study); established on deferasirox therapy for at least 1 year and suffering GI side effects believed to be related to their therapy as suggested by at least one of the following: - The temporal relationship of gastrointestinal side effects occurrence with the administration of deferasirox ….
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Patients with gastrointestinal symptoms assumed or known NOT to be caused by deferasirox. Patients who are treated for any condition with aspirin daily, patients under chronic steroid therapy and patients on anticoagulant therapy that could all lead to potential gastrointestinal symptoms/bleeding. Presence of gastrointestinal disease that may significantly alter the absorption of deferasirox (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, gastrointestinal or rectal bleeding). History of gastrointestinal surgery (except appendicitis and cholecystectomy) e.g. stomach/bowel surgery or awaiting elective surgery in the next 2 months. Undergoing acute medical intervention or hospitalization. Psychiatric illness (schizophrenia, major depression) which may interfere with study requirements Any other medical condition that, in the opinion of the site investigator would interfere with completing the study (visual problems or cognitive impairment. Platelet count less than 100 000 Currently on treatment for Hepatitis C Patients with severe iron loading in the heart (T2* less than 10 ms) and/or patients with severe total body iron load (liver iron concentration over 30 mg/g dry weight) Patients who have historical evidence of severe iron loading in the heart Women of child-bearing potential who are planning a pregnancy, pregnant, lactating and unwilling to use effective means of contraception. Inadequate renal function (e.g. Creatinine clearance < 60ml/min) Patients unwilling to stop using other iron chelation therapy for the trial duration Known allergy to the drug Patients on aluminium containing antacid preparations Patients who are on Vitamin C at doses higher than 200mg/day Patients receiving or having received any investigational drug within 30 days prior to study enrolment Patients unable to understand oral or written English
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method