Non-insulin-dependent Diabetes Mellitus and Insulin Resistance in Chronic Hepatitis C Patients Treated With Combination Therapy With Pegylated Interferon and Ribavirin in Taiwan
Sponsor study identifier
interventional
400
1 country
1
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)The influence of insulin sensitivity and glucose tolerance on the effects of antiviral therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the clinical and virological factors associated with sustained viral response in patients with combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of combination therapy on HOMA IR
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
May 28, 2008
Actual (reported)June 2008
Actual (reported)June 2008
Actual (reported)June 2, 2008
Actual (reported)Sustained virological response (SVR) rate, HCV RNA seronegative by PCR throughout 24-week off-treatment period; biochemical, virological and histological characteristics of CHC patients; HOMA-IR change after combination therapy
18 months
standard pegylated interferon alpha and ribavirin
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
pegylated interferon alpha and ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordKaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Mason AL, Lau JY, Hoang N, Qian K, Alexander GJ, Xu L, Guo L, Jacob S, Regenstein FG, Zimmerman R, Everhart JE, Wasserfall C, Maclaren NK, Perrillo RP. Association of diabetes mellitus and chronic hepatitis C virus infection. Hepatology. 1999 Feb;29(2):328-33. doi: 10.1002/hep.510290235.
Shintani Y, Fujie H, Miyoshi H, Tsutsumi T, Tsukamoto K, Kimura S, Moriya K, Koike K. Hepatitis C virus infection and diabetes: direct involvement of the virus in the development of insulin resistance. Gastroenterology. 2004 Mar;126(3):840-8. doi: 10.1053/j.gastro.2003.11.056.
Wan-Long Chuang, MD, PhD.
Department of Internal Medicine, Kaohsiung Medical University Hospital
400 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2008
First Posted
June 2, 2008
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Lecube A, Hernandez C, Simo R, Esteban JI, Genesca J. Glucose abnormalities are an independent risk factor for nonresponse to antiviral treatment in chronic hepatitis C. Am J Gastroenterol. 2007 Oct;102(10):2189-95. doi: 10.1111/j.1572-0241.2007.01402.x. Epub 2007 Jul 7.
Lee SD, Yu ML, Cheng PN, Lai MY, Chao YC, Hwang SJ, Chang WY, Chang TT, Hsieh TY, Liu CJ, Chen DS. Comparison of a 6-month course peginterferon alpha-2b plus ribavirin and interferon alpha-2b plus ribavirin in treating Chinese patients with chronic hepatitis C in Taiwan. J Viral Hepat. 2005 May;12(3):283-91. doi: 10.1111/j.1365-2893.2005.00590.x.
Romero-Gomez M, Del Mar Viloria M, Andrade RJ, Salmeron J, Diago M, Fernandez-Rodriguez CM, Corpas R, Cruz M, Grande L, Vazquez L, Munoz-De-Rueda P, Lopez-Serrano P, Gila A, Gutierrez ML, Perez C, Ruiz-Extremera A, Suarez E, Castillo J. Insulin resistance impairs sustained response rate to peginterferon plus ribavirin in chronic hepatitis C patients. Gastroenterology. 2005 Mar;128(3):636-41. doi: 10.1053/j.gastro.2004.12.049.
D'Souza R, Sabin CA, Foster GR. Insulin resistance plays a significant role in liver fibrosis in chronic hepatitis C and in the response to antiviral therapy. Am J Gastroenterol. 2005 Jul;100(7):1509-15. doi: 10.1111/j.1572-0241.2005.41403.x.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
August 6, 2009
Record last verified: 2008-05
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Source: ClinicalTrials.gov.
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