NCT01866072 - 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)

Arena U, Vizzutti F, Corti G, Ambu S, Stasi C, Bresci S, Moscarella S, Boddi V, Petrarca A, Laffi G, Marra F, Pinzani M
Acute viral hepatitis increases liver stiffness values measured by transient elastography. Hepatology. 2008 Feb;47(2):380-4.
Castera L, Forns X, Alberti A
Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26. Review.
de Lédinghen V, Vergniol J
Transient elastography for the diagnosis of liver fibrosis. Expert Rev Med Devices. 2010 Nov;7(6):811-23. doi: 10.1586/erd.10.46.
Garg H, Kumar A, Garg V, Sharma P, Sharma BC, Sarin SK
Clinical profile and predictors of mortality in patients of acute-on-chronic liver failure. Dig Liver Dis. 2012 Feb;44(2):166-71. doi: 10.1016/j.dld.2011.08.029. Epub 2011 Oct 5.
Kumar M, Satapathy S, Monga R, Das K, Hissar S, Pande C, Sharma BC, Sarin SK
A randomized controlled trial of lamivudine to treat acute hepatitis B. Hepatology. 2007 Jan;45(1):97-101.
Kumar M, Sharma P, Garg H, Kumar R, Bhatia V, Sarin SK
Transient elastographic evaluation in adult subjects without overt liver disease: influence of alanine aminotransferase levels. J Gastroenterol Hepatol. 2011 Aug;26(8):1318-25. doi: 10.1111/j.1440-1746.2011.06736.x.
McDONOUGH PG, Tho PT, Byrd JR
Twins discordant for 46,XX gonadal dysgenesis. Fertil Steril. 1977 Mar;28(3):251-2.
Roulot D, Czernichow S, Le Clésiau H, Costes JL, Vergnaud AC, Beaugrand M
Liver stiffness values in apparently healthy subjects: influence of gender and metabolic syndrome. J Hepatol. 2008 Apr;48(4):606-13. doi: 10.1016/j.jhep.2007.11.020. Epub 2008 Jan 3.

A Prospective Evaluation of the Role of Transient Elastography (Fibroscan) in Differentiating Patients of Acute Severe Viral Hepatitis and Acute on Chronic Liver Failure

Details for clinical trial NCT01866072

Clinical trial NCT01866072 - References