The Impact of Peginterferon Alpha-2a Maintenance Therapy on Portal Hypertension in Patients With Chronic Hepatitis C Virus Infection and Advanced Fibrosis and Cirrhosis Enrolled in the HALT-C Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2007
Actual (reported)Study Completion
September 2007
Actual (reported)The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus infections and advanced fibrosis or cirrhosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
November 9, 2005
Actual (reported)November 11, 2005
Actual (reported)September 2007
Actual (reported)September 2007
Actual (reported)Changes in portal pressure after 6 moths of treatment with peginterferon alfa-2a will be calculated by comparing portal pressure at the end of HALT-C to values obtained after 6 months of peginterferon.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.
Charlton M. Hepatitis C infection in liver transplantation. Am J Transplant. 2001 Sep;1(3):197-203. doi: 10.1034/j.1600-6143.2001.001003197.x.
Mitchell L. Shiffman, MD
Virignia Commonwealth University
60 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease
Contact the study team to confirm eligibility.
Poynard T, McHutchison J, Manns M, Trepo C, Lindsay K, Goodman Z, Ling MH, Albrecht J. Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology. 2002 May;122(5):1303-13. doi: 10.1053/gast.2002.33023.
Imai Y, Kawata S, Tamura S, Yabuuchi I, Noda S, Inada M, Maeda Y, Shirai Y, Fukuzaki T, Kaji I, Ishikawa H, Matsuda Y, Nishikawa M, Seki K, Matsuzawa Y. Relation of interferon therapy and hepatocellular carcinoma in patients with chronic hepatitis C. Osaka Hepatocellular Carcinoma Prevention Study Group. Ann Intern Med. 1998 Jul 15;129(2):94-9. doi: 10.7326/0003-4819-129-2-199807150-00005.
Shiffman ML, Hofmann CM, Contos MJ, Luketic VA, Sanyal AJ, Sterling RK, Ferreira-Gonzalez A, Mills AS, Garret C. A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia. Gastroenterology. 1999 Nov;117(5):1164-72. doi: 10.1016/s0016-5085(99)70402-6.
Lee WM, Dienstag JL, Lindsay KL, Lok AS, Bonkovsky HL, Shiffman ML, Everson GT, Di Bisceglie AM, Morgan TR, Ghany MG, Morishima C, Wright EC, Everhart JE; HALT-C Trial Group. Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders. Control Clin Trials. 2004 Oct;25(5):472-92. doi: 10.1016/j.cct.2004.08.003.
Garcia N Jr, Sanyal AJ. Portal hypertension. Clin Liver Dis. 2001 May;5(2):509-40. doi: 10.1016/s1089-3261(05)70176-8.
Primary Completion
September 2007
Actual (reported)Study Completion
September 2007
Actual (reported)Last Updated
March 20, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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