Clinical trial NCT01548690 - References

Acute Liver Failure — Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury

Citation(s)

•   Acharya SK, Bhatia V, Sreenivas V, Khanal S, Panda SK
  Efficacy of L-ornithine L-aspartate in acute liver failure: a double-blind, randomized, placebo-controlled study. Gastroenterology. 2009 Jun;136(7):2159-68. doi: 10.1053/j.gastro.2009.02.050.
•   Bhatia V, Singh R, Acharya SK
  Predictive value of arterial ammonia for complications and outcome in acute liver failure. Gut. 2006 Jan;55(1):98-104. Epub 2005 Jul 15.
•   Blei AT, Larsen FS
  Pathophysiology of cerebral edema in fulminant hepatic failure. J Hepatol. 1999 Oct;31(4):771-6. Review.
•   Blei AT
  Pathogenesis of brain edema in fulminant hepatic failure. Prog Liver Dis. 1995;13:311-30. Review.
•   Clemmesen JO, Larsen FS, Kondrup J, Hansen BA, Ott P
  Cerebral herniation in patients with acute liver failure is correlated with arterial ammonia concentration. Hepatology. 1999 Mar;29(3):648-53.
•   Cordoba J, Gottstein J, Blei AT
  Glutamine, myo-inositol, and organic brain osmolytes after portocaval anastomosis in the rat: implications for ammonia-induced brain edema. Hepatology. 1996 Oct;24(4):919-23.
•   Davies NA, Wright G, Ytrebø LM, Stadlbauer V, Fuskevåg OM, Zwingmann C, Davies DC, Habtesion A, Hodges SJ, Jalan R
  L-ornithine and phenylacetate synergistically produce sustained reduction in ammonia and brain water in cirrhotic rats. Hepatology. 2009 Jul;50(1):155-64. doi: 10.1002/hep.22897.
•   Ichai P, Duclos-Vallée JC, Guettier C, Hamida SB, Antonini T, Delvart V, Saliba F, Azoulay D, Castaing D, Samuel D
  Usefulness of corticosteroids for the treatment of severe and fulminant forms of autoimmune hepatitis. Liver Transpl. 2007 Jul;13(7):996-1003.
•   Jalan R, Lee WM
  Treatment of hyperammonemia in liver failure: a tale of two enzymes. Gastroenterology. 2009 Jun;136(7):2048-51. doi: 10.1053/j.gastro.2009.04.016. Epub 2009 May 3.
•   Jalan R, Olde Damink SW, Deutz NE, Hayes PC, Lee A
  Moderate hypothermia in patients with acute liver failure and uncontrolled intracranial hypertension. Gastroenterology. 2004 Nov;127(5):1338-46.
•   Jalan R, Wright G, Davies NA, Hodges SJ
  L-Ornithine phenylacetate (OP): a novel treatment for hyperammonemia and hepatic encephalopathy. Med Hypotheses. 2007;69(5):1064-9. Epub 2007 Apr 27.
•   Jalan R
  Pathophysiological basis of therapy of raised intracranial pressure in acute liver failure. Neurochem Int. 2005 Jul;47(1-2):78-83. Review.
•   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.
•   Larsen FS, Wendon J
  Prevention and management of brain edema in patients with acute liver failure. Liver Transpl. 2008 Oct;14 Suppl 2:S90-6. doi: 10.1002/lt.21643. Review.
•   Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Hynan LS, Reisch JS, Schiødt FV, Ostapowicz G, Shakil AO, Lee WM; Acute Liver Failure Study Group
  Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005 Dec;42(6):1364-72.
•   Lee WM, Hynan LS, Rossaro L, Fontana RJ, Stravitz RT, Larson AM, Davern TJ 2nd, Murray NG, McCashland T, Reisch JS, Robuck PR; Acute Liver Failure Study Group
  Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure. Gastroenterology. 2009 Sep;137(3):856-64, 864.e1. doi: 10.1053/j.gastro.2009.06.006. Epub 2009 Jun 12. Erratum in: Gastroenterology. 2013 Sep;145(3):695. Dosage error in article text.
•   Lee WM
  Etiologies of acute liver failure. Semin Liver Dis. 2008 May;28(2):142-52. doi: 10.1055/s-2008-1073114. Review.
•   Liou IW, Larson AM
  Role of liver transplantation in acute liver failure. Semin Liver Dis. 2008 May;28(2):201-9. doi: 10.1055/s-2008-1073119. Review.
•   Makin AJ, Wendon J, Williams R
  A 7-year experience of severe acetaminophen-induced hepatotoxicity (1987-1993). Gastroenterology. 1995 Dec;109(6):1907-16.
•   Novack, T
  (2000). The Orientation Log. The Center for Outcome Measurement in Brain Injury. http://www.tbims.org/combi/olog
•   O'Grady JG, Gimson AE, O'Brien CJ, Pucknell A, Hughes RD, Williams R
  Controlled trials of charcoal hemoperfusion and prognostic factors in fulminant hepatic failure. Gastroenterology. 1988 May;94(5 Pt 1):1186-92.
•   Polson J, Lee WM; American Association for the Study of Liver Disease
  AASLD position paper: the management of acute liver failure. Hepatology. 2005 May;41(5):1179-97.
•   Randomised trial of steroid therapy in acute liver failure
  Report from the European Association for the Study of the Liver (EASL). Gut. 1979 Jul;20(7):620-3.
•   Roberts MS, Angus DC, Bryce CL, Valenta Z, Weissfeld L
  Survival after liver transplantation in the United States: a disease-specific analysis of the UNOS database. Liver Transpl. 2004 Jul;10(7):886-97.
•   Rose C, Michalak A, Pannunzio M, Chatauret N, Rambaldi A, Butterworth RF
  Mild hypothermia delays the onset of coma and prevents brain edema and extracellular brain glutamate accumulation in rats with acute liver failure. Hepatology. 2000 Apr;31(4):872-7.
•   Rose C, Michalak A, Rao KV, Quack G, Kircheis G, Butterworth RF
  L-ornithine-L-aspartate lowers plasma and cerebrospinal fluid ammonia and prevents brain edema in rats with acute liver failure. Hepatology. 1999 Sep;30(3):636-40.
•   Sterling RK, Luketic VA, Sanyal AJ, Shiffman ML
  Treatment of fulminant hepatic failure with intravenous prostaglandin E1. Liver Transpl Surg. 1998 Sep;4(5):424-31.
•   Stravitz RT, Kramer AH, Davern T, Shaikh AO, Caldwell SH, Mehta RL, Blei AT, Fontana RJ, McGuire BM, Rossaro L, Smith AD, Lee WM; Acute Liver Failure Study Group
  Intensive care of patients with acute liver failure: recommendations of the U.S. Acute Liver Failure Study Group. Crit Care Med. 2007 Nov;35(11):2498-508.
•   Stravitz RT, Kramer DJ
  Management of acute liver failure. Nat Rev Gastroenterol Hepatol. 2009 Sep;6(9):542-53. doi: 10.1038/nrgastro.2009.127. Epub 2009 Aug 4. Review.
•   Stravitz RT, Larsen FS
  Therapeutic hypothermia for acute liver failure. Crit Care Med. 2009 Jul;37(7 Suppl):S258-64. doi: 10.1097/CCM.0b013e3181aa5fb8. Review.
•   Traber PG, Dal Canto M, Ganger DR, Blei AT
  Electron microscopic evaluation of brain edema in rabbits with galactosamine-induced fulminant hepatic failure: ultrastructure and integrity of the blood-brain barrier. Hepatology. 1987 Nov-Dec;7(6):1272-7.
•   Ytrebø LM, Kristiansen RG, Maehre H, Fuskevåg OM, Kalstad T, Revhaug A, Cobos MJ, Jalan R, Rose CF
  L-ornithine phenylacetate attenuates increased arterial and extracellular brain ammonia and prevents intracranial hypertension in pigs with acute liver failure. Hepatology. 2009 Jul;50(1):165-74. doi: 10.1002/hep.22917.
•   Zimmerman L, Jörnvall H, Bergström J
  Phenylacetylglutamine and hippuric acid in uremic and healthy subjects. Nephron. 1990;55(3):265-71.

A Phase 2a Study to Evaluate the Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure/Severe Acute Liver Injury

Details for clinical trial NCT01548690