Clinical trial NCT01379469 - References

Liver Cirrhosis — Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency

Citation(s)

•   Brent DA, Emslie GJ, Clarke GN, Asarnow J, Spirito A, Ritz L, Vitiello B, Iyengar S, Birmaher B, Ryan ND, Zelazny J, Onorato M, Kennard B, Mayes TL, Debar LL, McCracken JT, Strober M, Suddath R, Leonard H, Porta G, Keller MB
  Predictors of spontaneous and systematically assessed suicidal adverse events in the treatment of SSRI-resistant depression in adolescents (TORDIA) study. Am J Psychiatry. 2009 Apr;166(4):418-26. doi: 10.1176/appi.ajp.2008.08070976. Epub 2009 Feb 17. Erratum in: Am J Psychiatry. 2019 Sep 1;176(9):764.
•   Burroughs AK, Thalheimer U
  Hepatic venous pressure gradient in 2010: optimal measurement is key. Hepatology. 2010 Jun;51(6):1894-6. doi: 10.1002/hep.23710.
•   Chen P, Lin JJ, Lu CS, Ong CT, Hsieh PF, Yang CC, Tai CT, Wu SL, Lu CH, Hsu YC, Yu HY, Ro LS, Lu CT, Chu CC, Tsai JJ, Su YH, Lan SH, Sung SF, Lin SY, Chuang HP, Huang LC, Chen YJ, Tsai PJ, Liao HT, Lin YH, Chen CH, Chung WH, Hung SI, Wu JY, Chang CF, Chen L, Chen YT, Shen CY; Taiwan SJS Consortium
  Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan. N Engl J Med. 2011 Mar 24;364(12):1126-33. doi: 10.1056/NEJMoa1009717.
•   Cholongitas E, Senzolo M, Standish R, Marelli L, Quaglia A, Patch D, Dhillon AP, Burroughs AK
  A systematic review of the quality of liver biopsy specimens. Am J Clin Pathol. 2006 May;125(5):710-21. Review.
•   Chung WH, Hung SI, Hong HS, Hsih MS, Yang LC, Ho HC, Wu JY, Chen YT
  Medical genetics: a marker for Stevens-Johnson syndrome. Nature. 2004 Apr 1;428(6982):486.
•   Clark JM, Brancati FL, Diehl AM
  The prevalence and etiology of elevated aminotransferase levels in the United States. Am J Gastroenterol. 2003 May;98(5):960-7.
•   Delcò F, Tchambaz L, Schlienger R, Drewe J, Krähenbühl S
  Dose adjustment in patients with liver disease. Drug Saf. 2005;28(6):529-45. Review.
•   Dodson W
  , Carbamazepine and oxycarbazepine, Pediatric Epilepsy: Diagnosis and Therapy, P.J. Dodson W.E., Editor. 1993; Demos Publications: New York. 303-314.
•   Emslie GJ, Mayes T, Porta G, Vitiello B, Clarke G, Wagner KD, Asarnow JR, Spirito A, Birmaher B, Ryan N, Kennard B, DeBar L, McCracken J, Strober M, Onorato M, Zelazny J, Keller M, Iyengar S, Brent D
  Treatment of Resistant Depression in Adolescents (TORDIA): week 24 outcomes. Am J Psychiatry. 2010 Jul;167(7):782-91. doi: 10.1176/appi.ajp.2010.09040552. Epub 2010 May 17.
•   Eriksson S, Carlson J, Velez R
  Risk of cirrhosis and primary liver cancer in alpha 1-antitrypsin deficiency. N Engl J Med. 1986 Mar 20;314(12):736-9.
•   Frey B, Schubiger G, Musy JP
  Transient cholestatic hepatitis in a neonate associated with carbamazepine exposure during pregnancy and breast-feeding. Eur J Pediatr. 1990 Dec;150(2):136-8.
•   George J, Liddle C, Murray M, Byth K, Farrell GC
  Pre-translational regulation of cytochrome P450 genes is responsible for disease-specific changes of individual P450 enzymes among patients with cirrhosis. Biochem Pharmacol. 1995 Mar 30;49(7):873-81.
•   Hidvegi T
  , Perlmutter D.H., Watkins S., and Michalopoulos G., Carbamazepine ameliorates liver disease in mouse models of alpha-1-antitrypsin deficiency by enhancing intracellular disposal of the pathogenic aggregation-prone protein. Science; 2010; 329: 229-232.
•   Huband N, Ferriter M, Nathan R, Jones H
  Antiepileptics for aggression and associated impulsivity. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD003499. doi: 10.1002/14651858.CD003499.pub3. Review.
•   Ishizu H, Shiomi S, Kawamura E, Iwata Y, Nishiguchi S, Kawabe J, Ochi H
  Gastric emptying in patients with chronic liver diseases. Ann Nucl Med. 2002 May;16(3):177-82.
•   Kalambokis G, Manousou P, Vibhakorn S, Marelli L, Cholongitas E, Senzolo M, Patch D, Burroughs AK
  Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications--a systematic review. J Hepatol. 2007 Aug;47(2):284-94. Epub 2007 May 24. Review.
•   Kroenke K, Spitzer RL, Williams JB
  The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.
•   Malinchoc M, Kamath PS, Gordon FD, Peine CJ, Rank J, ter Borg PC
  A model to predict poor survival in patients undergoing transjugular intrahepatic portosystemic shunts. Hepatology. 2000 Apr;31(4):864-71.
•   Man CB, Kwan P, Baum L, Yu E, Lau KM, Cheng AS, Ng MH
  Association between HLA-B*1502 allele and antiepileptic drug-induced cutaneous reactions in Han Chinese. Epilepsia. 2007 May;48(5):1015-8. Erratum in: Epilepsia. 2008 May;49(5):941.
•   Manolakopoulos S, Triantos C, Theodoropoulos J, Vlachogiannakos J, Kougioumtzan A, Papatheodoridis G, Tzourmakliotis D, Karamanolis D, Burroughs AK, Archimandritis A, Raptis S, Avgerinos A
  Antiviral therapy reduces portal pressure in patients with cirrhosis due to HBeAg-negative chronic hepatitis B and significant portal hypertension. J Hepatol. 2009 Sep;51(3):468-74. doi: 10.1016/j.jhep.2009.05.031. Epub 2009 Jul 3.
•   McCormack M, Alfirevic A, Bourgeois S, Farrell JJ, Kasperaviciute D, Carrington M, Sills GJ, Marson T, Jia X, de Bakker PI, Chinthapalli K, Molokhia M, Johnson MR, O'Connor GD, Chaila E, Alhusaini S, Shianna KV, Radtke RA, Heinzen EL, Walley N, Pandolfo M, Pichler W, Park BK, Depondt C, Sisodiya SM, Goldstein DB, Deloukas P, Delanty N, Cavalleri GL, Pirmohamed M
  HLA-A*3101 and carbamazepine-induced hypersensitivity reactions in Europeans. N Engl J Med. 2011 Mar 24;364(12):1134-43. doi: 10.1056/NEJMoa1013297.
•   McNamara J
  , Drugs effective in the therapy of epilepsies, Goodman and Gillman's: The Pharmacological Basis of Therapeutics, J. Hardman, L. Limbird, and A. Cillman, Editors. 2001; McGraw-Hill: New York. 533-535.
•   Miller AD, Krauss GL, Hamzeh FM
  Improved CNS tolerability following conversion from immediate- to extended-release carbamazepine. Acta Neurol Scand. 2004 Jun;109(6):374-7.
•   Minozzi S, Amato L, Vecchi S, Davoli M
  Anticonvulsants for alcohol withdrawal. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD005064. doi: 10.1002/14651858.CD005064.pub3. Review.
•   Morgan DJ, McLean AJ
  Clinical pharmacokinetic and pharmacodynamic considerations in patients with liver disease. An update. Clin Pharmacokinet. 1995 Nov;29(5):370-91. Review.
•   Mueller TI, Stout RL, Rudden S, Brown RA, Gordon A, Solomon DA, Recupero PR
  A double-blind, placebo-controlled pilot study of carbamazepine for the treatment of alcohol dependence. Alcohol Clin Exp Res. 1997 Feb;21(1):86-92.
•   Parlesak A, Schäfer C, Schütz T, Bode JC, Bode C
  Increased intestinal permeability to macromolecules and endotoxemia in patients with chronic alcohol abuse in different stages of alcohol-induced liver disease. J Hepatol. 2000 May;32(5):742-7.
•   Perlmutter D
  H., Alpha-1-Antitrypsin Deficiency, in Schiff's Disease of Liver, Schiff E.R., Maddrey W.C., Editor. 2007; Lippincott-Raven: Philadelphia. 1063-1084.
•   Perlmutter DH
  Autophagic disposal of the aggregation-prone protein that causes liver inflammation and carcinogenesis in alpha-1-antitrypsin deficiency. Cell Death Differ. 2009 Jan;16(1):39-45. doi: 10.1038/cdd.2008.103. Epub 2008 Jul 11. Review.
•   Perlmutter DH
  Pathogenesis of chronic liver injury and hepatocellular carcinoma in alpha-1-antitrypsin deficiency. Pediatr Res. 2006 Aug;60(2):233-8. Review.
•   Piitulainen E, Carlson J, Ohlsson K, Sveger T
  Alpha1-antitrypsin deficiency in 26-year-old subjects: lung, liver, and protease/protease inhibitor studies. Chest. 2005 Oct;128(4):2076-81.
•   Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R
  Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973 Aug;60(8):646-9.
•   Roberts S, Gordon A, McLean C, Pedersen J, Bowden S, Thomson K, Angus P
  Effect of sustained viral response on hepatic venous pressure gradient in hepatitis C-related cirrhosis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):932-7. Epub 2007 Jun 4.
•   Rodriquez A, Martin A, Oterino JA, Blanco I, Jimenez M, Perez A, Novoa JM
  Renal function in compensated hepatic cirrhosis: effects of an amino acid infusion and relationship with nitric acid. Dig Dis. 1999;17(4):235-40.
•   Rudnick DA, Perlmutter DH
  Alpha-1-antitrypsin deficiency: a new paradigm for hepatocellular carcinoma in genetic liver disease. Hepatology. 2005 Sep;42(3):514-21. Review.
•   Sarkar S, Floto RA, Berger Z, Imarisio S, Cordenier A, Pasco M, Cook LJ, Rubinsztein DC
  Lithium induces autophagy by inhibiting inositol monophosphatase. J Cell Biol. 2005 Sep 26;170(7):1101-11.
•   Shemesh E, Shneider BL, Savitzky JK, Arnott L, Gondolesi GE, Krieger NR, Kerkar N, Magid MS, Stuber ML, Schmeidler J, Yehuda R, Emre S
  Medication adherence in pediatric and adolescent liver transplant recipients. Pediatrics. 2004 Apr;113(4):825-32.
•   Sveger T
  Liver disease in alpha1-antitrypsin deficiency detected by screening of 200,000 infants. N Engl J Med. 1976 Jun 10;294(24):1316-21.
•   Tandra S, Vuppalanchi R
  Use of statins in patients with liver disease. Curr Treat Options Cardiovasc Med. 2009 Aug;11(4):272-8.
•   Verbeeck RK, Horsmans Y
  Effect of hepatic insufficiency on pharmacokinetics and drug dosing. Pharm World Sci. 1998 Oct;20(5):183-92. Review.
•   Vibhakorn S, Cholongitas E, Kalambokis G, Manousou P, Quaglia A, Marelli L, Senzolo M, Patch D, Dhillon A, Burroughs AK
  A comparison of four- versus three-pass transjugular biopsy using a 19-G Tru-Cut needle and a randomized study using a cassette to prevent biopsy fragmentation. Cardiovasc Intervent Radiol. 2009 May;32(3):508-13. doi: 10.1007/s00270-008-9412-7. Epub 2008 Aug 13.
•   Vigo DV, Baldessarini RJ
  Anticonvulsants in the treatment of major depressive disorder: an overview. Harv Rev Psychiatry. 2009;17(4):231-41. doi: 10.1080/10673220903129814. Review.
•   Wada JA, Troupin AS, Friel P, Remick R, Leal K, Pearmain J
  Pharmacokinetic comparison of tablet and suspension dosage forms of carbamazepine. Epilepsia. 1978 Jun;19(3):251-5.
•   Wilkinson GR, Schenker S
  Drug disposition and liver disease. Drug Metab Rev. 1975;4(2):139-75. Review.
•   Williams RS, Cheng L, Mudge AW, Harwood AJ
  A common mechanism of action for three mood-stabilizing drugs. Nature. 2002 May 16;417(6886):292-5.
•   Zakrzewska JM
  Medical management of trigeminal neuropathic pains. Expert Opin Pharmacother. 2010 Jun;11(8):1239-54. doi: 10.1517/14656561003767449. Review.
•   Zoli M, Iervese T, Merkel C, Bianchi G, Magalotti D, Marchesini G, Gatta A, Pisi E
  Prognostic significance of portal hemodynamics in patients with compensated cirrhosis. J Hepatol. 1993 Jan;17(1):56-61.

A Preliminary Study of the Efficacy and Safety of Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency

Details for clinical trial NCT01379469