NCT02067130 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Argyropoulou MI, Astrakas L
MRI evaluation of tissue iron burden in patients with beta-thalassaemia major. Pediatr Radiol. 2007 Dec;37(12):1191-200; quiz 1308-9. Epub 2007 Aug 21. Review.
Gandon Y, Olivié D, Guyader D, Aubé C, Oberti F, Sebille V, Deugnier Y
Non-invasive assessment of hepatic iron stores by MRI. Lancet. 2004 Jan 31;363(9406):357-62.
Hou P, Popat UR, Lindsay RJ, Jackson EF, Choi H
A practical approach for a wide range of liver iron quantitation using a magnetic resonance imaging technique. Radiol Res Pract. 2012;2012:207391. doi: 10.1155/2012/207391. Epub 2012 Dec 11.
Jung KS, Kim SU
Clinical applications of transient elastography. Clin Mol Hepatol. 2012 Jun;18(2):163-73. doi: 10.3350/cmh.2012.18.2.163. Epub 2012 Jun 26. Review.
Loustaud-Ratti VR, Cypierre A, Rousseau A, Yagoubi F, Abraham J, Fauchais AL, Carrier P, Lefebvre A, Bordessoule D, Vidal E, Sautereau D, Jaccard A
Non-invasive detection of hepatic amyloidosis: FibroScan, a new tool. Amyloid. 2011 Mar;18(1):19-24. doi: 10.3109/13506129.2010.543443. Epub 2011 Jan 10.
Remacha A, Sanz C, Contreras E, De Heredia CD, Grifols JR, Lozano M, Nuñez GM, Salinas R, Corral M, Villegas A; Spanish Society of Blood Transfusion; Spanish Society of Haematology and Haemotherapy
Guidelines on haemovigilance of post-transfusional iron overload. Blood Transfus. 2013 Jan;11(1):128-39. doi: 10.2450/2012.0114-11. Epub 2012 Jul 4. Review.
Shander A, Sazama K
Clinical consequences of iron overload from chronic red blood cell transfusions, its diagnosis, and its management by chelation therapy. Transfusion. 2010 May;50(5):1144-55. doi: 10.1111/j.1537-2995.2009.02551.x. Epub 2010 Jan 15. Review.

Utility of Transient Elastography (Fibroscan) in Estimating Hepatic Iron Concentration in Comparison to MRI in Patients With Transfusion Dependent Hemoglobinopathies

Details for clinical trial NCT02067130

Clinical trial NCT02067130 - References