NCT00495131|CompletedPhase 4ResultsDMC
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Sponsor study identifier
interventional
308
1 country
6
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the world's population. The current standard of therapy is pegylated interferon and ribavirin, reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week course of combination therapy has achieved a higher successful rate that a 24 weeks course of therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has comparable or even better response to a 48 week course of therapy in Western countries. Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
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.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 29, 2007
Actual (reported)July 2, 2007
Actual (reported)June 2008
Actual (reported)July 2008
Actual (reported)September 7, 2009
Actual (reported)Sustained Virologic Response
Undetectable HCV RNA 6 months off therapy
18 months
Sustained Biochemical Response
Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization
18 months
Treatment-related Withdrawal Rate
18 months
Histologic Response
18 months
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Pegylated interferon alfa-2a plus ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Pegylated interferon alfa-2a plus ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNational Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Buddhist Tzu Chi General Hospital
Taipei, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
Ren-Ai Branch, Taipei Municipal Hospital
Taipei, Taiwan
McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, Ling MH, Cort S, Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. 1998 Nov 19;339(21):1485-92. doi: 10.1056/NEJM199811193392101.
Poynard T, Marcellin P, Lee SS, Niederau C, Minuk GS, Ideo G, Bain V, Heathcote J, Zeuzem S, Trepo C, Albrecht J. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet. 1998 Oct 31;352(9138):1426-32. doi: 10.1016/s0140-6736(98)07124-4.
Jia-Horng Kao, MD, PhD
National Taiwan University Hospital
Ding-Shinn Chen, MD
National Taiwan University Hospital
Ming-Yang Lai, MD, PhD
National Taiwan University Hospital
Pei-Jer Chen, MD, PhD
National Taiwan University Hospital
308 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2007
First Posted
July 2, 2007
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lai MY, Kao JH, Yang PM, Wang JT, Chen PJ, Chan KW, Chu JS, Chen DS. Long-term efficacy of ribavirin plus interferon alfa in the treatment of chronic hepatitis C. Gastroenterology. 1996 Nov;111(5):1307-12. doi: 10.1053/gast.1996.v111.pm8898645.
Chemello L, Cavalletto L, Bernardinello E, Guido M, Pontisso P, Alberti A. The effect of interferon alfa and ribavirin combination therapy in naive patients with chronic hepatitis C. J Hepatol. 1995;23 Suppl 2:8-12.
Reichard O, Norkrans G, Fryden A, Braconier JH, Sonnerborg A, Weiland O. Randomised, double-blind, placebo-controlled trial of interferon alpha-2b with and without ribavirin for chronic hepatitis C. The Swedish Study Group. Lancet. 1998 Jan 10;351(9096):83-7. doi: 10.1016/s0140-6736(97)06088-1.
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.
Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.
Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. doi: 10.1056/NEJMoa020047.
Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010.
National Institutes of Health. National Institutes of Health Consensus Development Conference Statement: Management of hepatitis C: 2002--June 10-12, 2002. Hepatology. 2002 Nov;36(5 Suppl 1):S3-20. doi: 10.1053/jhep.2002.37117. No abstract available.
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.
Yu ML, Dai CY, Lin ZY, Lee LP, Hou NJ, Hsieh MY, Chen SC, Hsieh MY, Wang LY, Chang WY, Chuang WL. A randomized trial of 24- vs. 48-week courses of PEG interferon alpha-2b plus ribavirin for genotype-1b-infected chronic hepatitis C patients: a pilot study in Taiwan. Liver Int. 2006 Feb;26(1):73-81. doi: 10.1111/j.1478-3231.2005.01196.x.
Liu CH, Liu CJ, Lin CL, Liang CC, Hsu SJ, Yang SS, Hsu CS, Tseng TC, Wang CC, Lai MY, Chen JH, Chen PJ, Chen DS, Kao JH. Pegylated interferon-alpha-2a plus ribavirin for treatment-naive Asian patients with hepatitis C virus genotype 1 infection: a multicenter, randomized controlled trial. Clin Infect Dis. 2008 Nov 15;47(10):1260-9. doi: 10.1086/592579.
Chun-Jen Liu, MD, PhD
National Taiwan University Hospital
Chen-Hua Liu, MD
National Taiwan University Hospital
Shih-Jer Hsu, MD
National Taiwan University Hosptial, Yun-Lin Branch
Chih-Lin Lin, MD
Ren-Ai Branch, Taipei City Hospital
Cheng-Chao Liang, MD
Far Eastern Memorial Hospital
Ching-Sheng Hsu, MD
Buddhist Tzu Chi General Hospital
Sheng-Shun Yang, MD
Taichung Veterans General Hospital
Primary Completion
June 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
September 10, 2009
Results First Posted
September 7, 2009
Record last verified: 2009-09
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Source: ClinicalTrials.gov.
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