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Unraveling the Mechanisms of Non-Response in Patients With and Without Cirrhosis Due to Chronic Hepatitis C
Sponsor study identifier
Secondary identifiers
OTHER · National Institutes of Health
interventional
35
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Background: \- Some people who have chronic hepatitis C do not respond to the usual treatment with peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may work better for different people. The treatments will look at how specific genes interact with the drugs. Researchers want to see how well these new drugs work in people whose chronic hepatitis C has not responded or only partly responded to the usual treatment drugs. Objectives: \- To compare new treatments for people with chronic hepatitis C. Eligibility: \- Individuals at least 18 years of age who have chronic hepatitis C that has not responded to standard treatments. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
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.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2013
Actual (reported)June 28, 2013
Actual (reported)November 2015
Actual (reported)November 2015
Actual (reported)December 12, 2016
Actual (reported)Changes in Interferon Stimulated Genes in the Liver
Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression. The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray.
baseline and either 2 or 4 weeks
Rates of Rapid Virological Responder
Week 4 post treatment
Extended Rapid Virological Responder
Both weeks 4 and 12 post treatment
Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy.
Asunaprevir and Daclatsvir
Asunaprevir, daclatsvir, peginterferon and ribavirin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis. 2005 Sep;5(9):558-67. doi: 10.1016/S1473-3099(05)70216-4.
Lavanchy D. The global burden of hepatitis C. Liver Int. 2009 Jan;29 Suppl 1:74-81. doi: 10.1111/j.1478-3231.2008.01934.x.
Esteban JI, Sauleda S, Quer J. The changing epidemiology of hepatitis C virus infection in Europe. J Hepatol. 2008 Jan;48(1):148-62. doi: 10.1016/j.jhep.2007.07.033. Epub 2007 Nov 5.
Marc G Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
35 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2013
First Posted
June 28, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
End of Treatment Responder
Week 24 post treatment
Sustained Virological Responder
Week 12 post treatment
Serum Aminotransferase Levels
Week 12 post treatment
Contact the study team to confirm eligibility.
Serti E, Park H, Keane M, O'Keefe AC, Rivera E, Liang TJ, Ghany M, Rehermann B. Rapid decrease in hepatitis C viremia by direct acting antivirals improves the natural killer cell response to IFNalpha. Gut. 2017 Apr;66(4):724-735. doi: 10.1136/gutjnl-2015-310033. Epub 2016 Jan 4.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
February 7, 2017
Results First Posted
December 12, 2016
Record last verified: 2016-12
Patients will have serum stored from selected time points during this study. These specimens will be used for repeat virological testing and special tests as needed (such as for viral levels, HCV RNA sequencing, HCV resistance testing or measurement of serum levels of cytokines, IL28b testing or interferon induced genes) and for future research.
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.
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