EUCTR2010-023217-61-GB
Active, not recruiting
Not Applicable
A phase IV, open-label, partial cross-over partial parallel, randomized, multi-centre study to compare the gastrointestinal tolerability of once daily oral deferasirox, when administered before or after food in patients with transfusional haemosiderosis. - DEFERASIROX GASTROINTESTINAL TOLERABILITY STUDY
niversity College London0 sites64 target enrollmentJanuary 5, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- transfusional haemosiderosis
- Sponsor
- niversity College London
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of protease inhibitors to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/mlNL-OMON39957niversitair Medisch Centrum Utrecht24
Active, not recruiting
Not Applicable
RAltegravir Switch STudy: effects on Endothelial RecoveryEUCTR2011-003298-26-NLniversity Medical Center Utrecht24
Active, not recruiting
Not Applicable
A PHASE IV, OPEN-LABEL, RANDOMISED, CROSS-OVER STUDY TO ASSESS PATIENT PREFERENCE AND HEALTH ECONOMY IN PATIENTS WITH NEUROENDOCRINE TUMOURS, TREATED WITH LANREOTIDE AUTOGEL GIVEN AS SELF ADMINISTRATIOEUCTR2007-006514-42-SEInstitut Produits Synthèse (IPSEN) AB42
Active, not recruiting
Not Applicable
A PHASE IV, OPEN-LABEL, RANDOMISED, CROSS-OVER STUDY TO ASSESS PATIENT PREFERENCE AND HEALTH ECONOMY IN PATIENTS WITH NEUROENDOCRINE TUMOURS, TREATED WITH LANREOTIDE AUTOGEL GIVEN AS SELF ADMINISTRATIOSymptoms associated with carcinoid syndrome in patients with neuroendocrine tumoursMedDRA version: 9.1Level: LLTClassification code 10007270Term: Carcinoid syndromeEUCTR2007-006514-42-DKInstitut Produits Synthèse (IPSEN) AB26
Completed
Not Applicable
A phase I, open-label, randomized, 4-way crossover study in subjects with chronic Hepatitis B virus infection to assess pharmacokinetics (fasted/fed), safety, tolerability and pharmacodynamics of single oral doses of Farnesoid X receptor agonist EYP001a.Hepatitis Bviral infection of the liver10019654NL-OMON45541ENYO Pharma SA14