Clinical trials: Overload
Iron Overload Due to Repeated Red Blood Cell Transfusions
Pharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy
The purpose of this study is to evaluate SSP-004184AQ in patients with transfusional iron overload whose primary diagnosis is hereditary or congenital anemia.
- Trial name
- NCT01604941
- Testing
- SPD602
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 32 people
- Sponsor
- Shire
Iron Overload Due to Repeated Red Blood Cell Transfusions
Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using FBS0701 (SSP-004184)
The purpose of this extension study is to evaluate SSP-004184AQ in patients with transfusional iron overload and to provide data on long term safety and efficacy.
- Trial name
- NCT01671111
- Testing
- SSP-004184AQ
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 30 people
- Sponsor
- Shire
Myelodysplastic Syndromes, Iron Overload
Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic…
- Trial name
- NCT00117507
- Testing
- Deferasirox
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Beta-thalassemia, Iron Overload
Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment
The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.
- Trial name
- NCT00447694
- Testing
- Deferasirox
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis
Transfusional Iron Overload, Beta-Thalassemia
Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the…
- Trial name
- NCT01363908
- Testing
- SPD602
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 30 people
- Sponsor
- Shire
Transfusional Iron Overload, Beta-thalassemia
Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new oral iron chelator, and its effectiveness in clearing iron from the liver.
- Trial name
- NCT01186419
- Testing
- SPD602 (FBS0701, SSP-004184)
- Where
- 9 sites in United States, Italy and 3 more
- Volunteers
- 51 people
- Sponsor
- Shire
Chronic Iron Overload
Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients
Multicentre, randomised, open label, non-inferiority active-controlled trial to evaluate efficacy and safety of a 12-months treatment with deferiprone (DFP) at dose of 75-100 mg/kg/day versus deferasirox (DFX) at dose of 20-40…
- Trial name
- NCT01825512
- Testing
- Deferiprone, Deferasirox
- Where
- 22 sites in Albania, Cyprus and 5 more
- Volunteers
- 435 people
- Sponsor
- Consorzio per Valutazioni Biologiche e Farmacologiche
Iron Overload
Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis
This study employed a prospective, single-arm, global multi-center interventional open-label, non-randomized design to identify and assess safety profile of the crushed deferasirox FCT when administered up to 24 weeks in…
- Trial name
- MIMAS (NCT03372083)
- Testing
- Deferasirox
- Where
- 10 sites in Egypt, Italy and 5 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Fluid Overload
Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs
Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.
- Trial name
- NCT03789474
- Testing
- HUNTLEIGH FLOWTRON ACS900
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- All India Institute of Medical Sciences, Rishikesh
Chronic Iron Overload
Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
- Trial name
- NCT02720536
- Testing
- Deferasirox
- Where
- 14 sites in Austria, Greece and 1 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Transfusion-dependent β-thalassemia Patients, Cardiac Iron Overload
Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload
The primary efficacy endpoint of this interventional study was to evaluate the number of patients achieving a complete response (CR), defined as patients switching from intensive deferasirox -DFO treatment, at any time point…
- Trial name
- NCT01459718
- Testing
- Deferasirox, Deferoxamine (DFO)
- Where
- 4 sites in Greece
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Iron Overload, Accelerated Phase Chronic Myelogenous Leukemia
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload
RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload.
- Conditions
- Iron Overload, Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
- Trial name
- NCT01159067
- Testing
- deferasirox
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- City of Hope Medical Center
Iron Overload, Excessive Body Iron Burden
Massive Iron Deposit Assessment
Iron overload is a severe complication of multiple blood transfusions. As the body has no physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in organs and lead to iron toxicity.
- Trial name
- NCT01572922
- Testing
- R2*-UTE, R2*-GRE, Liver biopsy
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- St. Jude Children's Research Hospital
Thalassemia Major With Severe Transfusional Iron Overload
Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia
We hypothesize that the combination treatment with deferasirox and deferiprone will be well tolerated and will result in significant improvement in cardiac and liver iron levels.
- Trial name
- NCT01709032
- Testing
- Deferasirox and deferiprone
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Children's Hospital of Philadelphia
Breast Cancer, Iron Overload
Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant.
- Conditions
- Breast Cancer, Iron Overload, Leukemia, Lymphoma
- Trial name
- NCT00602446
- Testing
- deferasirox
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Fluid Overload, Anesthesia; Adverse Effect, Spinal and Epidural
Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Patients?
Aim of this study is to determine whether Inferior Vena Cava analyzed by trans-thoracic echocardiography is an effective method to guide titrated fluid repletion in non critical patients, in order both to decrease post procedural…
- Conditions
- Fluid Overload, Anesthesia; Adverse Effect, Spinal and Epidural, Regional Anesthesia Morbidity
- Trial name
- NCT02271477
- Testing
- Ultrasound-guided volemic repletion
- Where
- Switzerland
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
Chronic Iron Overload Due to Transfusion-dependant Anemias
Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)
Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance
- Trial name
- NCT02125877
- Testing
- Deferasirox dispersible tablet, Defearisox film-coated tablet
- Where
- 51 sites in United States, Argentina and 14 more
- Volunteers
- 173 people
- Sponsor
- Novartis Pharmaceuticals
Iron Overload
Non-invasive Quantification of Liver Iron With MRI
This study is being conducted to build a library of prospectively collected clinical data from subjects with iron overload examined with commercially available MRI devices.
- Trial name
- NCT02425956
- Testing
- GE Optima/Discovery® MRI data of the liver
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- GE Healthcare
Thalassemia, Non-transfusional-dependent Thalassemia (NTDT), Myeloplastic Dysplasia (MDS), Other Anemia
An Epidemiological Study to Assess Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study)
Iron, one of the most common elements in nature and the most abundant transition metal in the body, is readily capable of accepting and donating electrons.
- Trial name
- NCT01736540
- Testing
- MRI scan
- Where
- 13 sites in Australia
- Volunteers
- 243 people
- Sponsor
- Novartis Pharmaceuticals
Transfusional Iron Overload, β-thalassemia Major
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed.
- Conditions
- Transfusional Iron Overload, β-thalassemia Major, Pediatric Rare Anemia
- Trial name
- NCT00390858
- Testing
- Deferasirox
- Where
- 4 sites in France, Italy
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals