NCT00466271|CompletedDMC
Loading search results
Sponsor study identifier
observational
102
1 country
1
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
December 2008
Actual (reported)The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2007
Actual (reported)April 27, 2007
Actual (reported)November 2008
Actual (reported)December 2008
Actual (reported)HCV carriers with persistently normal ALT levels who will receive percutaneous liver biopsy
National Taiwan University Hospital
Taipei, 100, Taiwan
Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
Bacon BR. Treatment of patients with hepatitis C and normal serum aminotransferase levels. Hepatology. 2002 Nov;36(5 Suppl 1):S179-84. doi: 10.1053/jhep.2002.36386.
EASL International Consensus Conference on Hepatitis C. Paris, 26-28, February 1999, Consensus Statement. European Association for the Study of the Liver. J Hepatol. 1999 May;30(5):956-61. No abstract available.
Chen-Hua Liu, MD
Department of Internal Medicine, National Taiwan Universitys Hospital
102 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2007
First Posted
April 27, 2007
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR
Contact the study team to confirm eligibility.
Puoti C, Guido M, Mangia A, Persico M, Prati D; Committee on HCV carriers with normal alanine aminotransferase levels of the Italian Association for the Study of the Liver. Clinical management of HCV carriers with normal aminotransferase levels. Dig Liver Dis. 2003 May;35(5):362-9. doi: 10.1016/s1590-8658(03)00185-3.
Gholson CF, Morgan K, Catinis G, Favrot D, Taylor B, Gonzalez E, Balart L. Chronic hepatitis C with normal aminotransferase levels: a clinical histologic study. Am J Gastroenterol. 1997 Oct;92(10):1788-92.
Puoti C, Magrini A, Stati T, Rigato P, Montagnese F, Rossi P, Aldegheri L, Resta S. Clinical, histological, and virological features of hepatitis C virus carriers with persistently normal or abnormal alanine transaminase levels. Hepatology. 1997 Dec;26(6):1393-8. doi: 10.1053/jhep.1997.v26.pm0009397976.
Conry-Cantilena C, VanRaden M, Gibble J, Melpolder J, Shakil AO, Viladomiu L, Cheung L, DiBisceglie A, Hoofnagle J, Shih JW, et al. Routes of infection, viremia, and liver disease in blood donors found to have hepatitis C virus infection. N Engl J Med. 1996 Jun 27;334(26):1691-6. doi: 10.1056/NEJM199606273342602.
Pradat P, Alberti A, Poynard T, Esteban JI, Weiland O, Marcellin P, Badalamenti S, Trepo C. Predictive value of ALT levels for histologic findings in chronic hepatitis C: a European collaborative study. Hepatology. 2002 Oct;36(4 Pt 1):973-7. doi: 10.1053/jhep.2002.35530.
Alberti A, Noventa F, Benvegnu L, Boccato S, Gatta A. Prevalence of liver disease in a population of asymptomatic persons with hepatitis C virus infection. Ann Intern Med. 2002 Dec 17;137(12):961-4. doi: 10.7326/0003-4819-137-12-200212170-00009.
Persico M, Persico E, Suozzo R, Conte S, De Seta M, Coppola L, Palmentieri B, Sasso FC, Torella R. Natural history of hepatitis C virus carriers with persistently normal aminotransferase levels. Gastroenterology. 2000 Apr;118(4):760-4. doi: 10.1016/s0016-5085(00)70145-4.
Martinot-Peignoux M, Boyer N, Cazals-Hatem D, Pham BN, Gervais A, Le Breton V, Levy S, Degott C, Valla DC, Marcellin P. Prospective study on anti-hepatitis C virus-positive patients with persistently normal serum alanine transaminase with or without detectable serum hepatitis C virus RNA. Hepatology. 2001 Nov;34(5):1000-5. doi: 10.1053/jhep.2001.28458.
Mathurin P, Moussalli J, Cadranel JF, Thibault V, Charlotte F, Dumouchel P, Cazier A, Huraux JM, Devergie B, Vidaud M, Opolon P, Poynard T. Slow progression rate of fibrosis in hepatitis C virus patients with persistently normal alanine transaminase activity. Hepatology. 1998 Mar;27(3):868-72. doi: 10.1002/hep.510270333.
Jamal MM, Soni A, Quinn PG, Wheeler DE, Arora S, Johnston DE. Clinical features of hepatitis C-infected patients with persistently normal alanine transaminase levels in the Southwestern United States. Hepatology. 1999 Nov;30(5):1307-11. doi: 10.1002/hep.510300526.
Okanoue T, Makiyama A, Nakayama M, Sumida Y, Mitsuyoshi H, Nakajima T, Yasui K, Minami M, Itoh Y. A follow-up study to determine the value of liver biopsy and need for antiviral therapy for hepatitis C virus carriers with persistently normal serum aminotransferase. J Hepatol. 2005 Oct;43(4):599-605. doi: 10.1016/j.jhep.2005.04.008.
Hui CK, Belaye T, Montegrande K, Wright TL. A comparison in the progression of liver fibrosis in chronic hepatitis C between persistently normal and elevated transaminase. J Hepatol. 2003 Apr;38(4):511-7. doi: 10.1016/s0168-8278(03)00004-7.
Zeuzem S, Diago M, Gane E, Reddy KR, Pockros P, Prati D, Shiffman M, Farci P, Gitlin N, O'Brien CB, Lamour F, Lardelli P; PEGASYS Study NR16071 Investigator Group. Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with chronic hepatitis C and normal aminotransferase levels. Gastroenterology. 2004 Dec;127(6):1724-32. doi: 10.1053/j.gastro.2004.09.050.
Piccinino F, Sagnelli E, Pasquale G, Giusti G. Complications following percutaneous liver biopsy. A multicentre retrospective study on 68,276 biopsies. J Hepatol. 1986;2(2):165-73. doi: 10.1016/s0168-8278(86)80075-7.
Cadranel JF, Rufat P, Degos F. Practices of liver biopsy in France: results of a prospective nationwide survey. For the Group of Epidemiology of the French Association for the Study of the Liver (AFEF). Hepatology. 2000 Sep;32(3):477-81. doi: 10.1053/jhep.2000.16602.
McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology. 1990 Nov;99(5):1396-400. doi: 10.1016/0016-5085(90)91167-5.
Maharaj B, Maharaj RJ, Leary WP, Cooppan RM, Naran AD, Pirie D, Pudifin DJ. Sampling variability and its influence on the diagnostic yield of percutaneous needle biopsy of the liver. Lancet. 1986 Mar 8;1(8480):523-5. doi: 10.1016/s0140-6736(86)90883-4.
Bedossa P, Dargere D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatology. 2003 Dec;38(6):1449-57. doi: 10.1016/j.hep.2003.09.022.
Colloredo G, Guido M, Sonzogni A, Leandro G. Impact of liver biopsy size on histological evaluation of chronic viral hepatitis: the smaller the sample, the milder the disease. J Hepatol. 2003 Aug;39(2):239-44. doi: 10.1016/s0168-8278(03)00191-0.
Giannini E, Risso D, Botta F, Chiarbonello B, Fasoli A, Malfatti F, Romagnoli P, Testa E, Ceppa P, Testa R. Validity and clinical utility of the aspartate aminotransferase-alanine aminotransferase ratio in assessing disease severity and prognosis in patients with hepatitis C virus-related chronic liver disease. Arch Intern Med. 2003 Jan 27;163(2):218-24. doi: 10.1001/archinte.163.2.218.
Imbert-Bismut F, Ratziu V, Pieroni L, Charlotte F, Benhamou Y, Poynard T; MULTIVIRC Group. Biochemical markers of liver fibrosis in patients with hepatitis C virus infection: a prospective study. Lancet. 2001 Apr 7;357(9262):1069-75. doi: 10.1016/S0140-6736(00)04258-6.
Poynard T, Bedossa P. Age and platelet count: a simple index for predicting the presence of histological lesions in patients with antibodies to hepatitis C virus. METAVIR and CLINIVIR Cooperative Study Groups. J Viral Hepat. 1997 May;4(3):199-208. doi: 10.1046/j.1365-2893.1997.00141.x.
Wai CT, Greenson JK, Fontana RJ, Kalbfleisch JD, Marrero JA, Conjeevaram HS, Lok AS. A simple noninvasive index can predict both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology. 2003 Aug;38(2):518-26. doi: 10.1053/jhep.2003.50346.
Castera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, Darriet M, Couzigou P, De Ledinghen V. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology. 2005 Feb;128(2):343-50. doi: 10.1053/j.gastro.2004.11.018.
Colletta C, Smirne C, Fabris C, Toniutto P, Rapetti R, Minisini R, Pirisi M. Value of two noninvasive methods to detect progression of fibrosis among HCV carriers with normal aminotransferases. Hepatology. 2005 Oct;42(4):838-45. doi: 10.1002/hep.20814.
Sebastiani G, Vario A, Guido M, Noventa F, Plebani M, Pistis R, Ferrari A, Alberti A. Stepwise combination algorithms of non-invasive markers to diagnose significant fibrosis in chronic hepatitis C. J Hepatol. 2006 Apr;44(4):686-93. doi: 10.1016/j.jhep.2006.01.007. Epub 2006 Feb 8.
Fabris C, Smirne C, Toniutto P, Colletta C, Rapetti R, Minisini R, Falleti E, Pirisi M. Assessment of liver fibrosis progression in patients with chronic hepatitis C and normal alanine aminotransferase values: the role of AST to the platelet ratio index. Clin Biochem. 2006 Apr;39(4):339-43. doi: 10.1016/j.clinbiochem.2006.01.011. Epub 2006 Feb 20.
Liu CH, Lin JW, Tsai FC, Yang PM, Lai MY, Chen JH, Kao JH, Chen DS. Noninvasive tests for the prediction of significant hepatic fibrosis in hepatitis C virus carriers with persistently normal alanine aminotransferases. Liver Int. 2006 Nov;26(9):1087-94. doi: 10.1111/j.1478-3231.2006.01355.x.
Primary Completion
November 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Last Updated
December 23, 2008
Record last verified: 2008-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: