Sponsor study identifier
observational
74
1 country
1
Study Start
January 2015
Actual (reported)Primary Completion
December 11, 2017
Actual (reported)Study Completion
December 11, 2017
Actual (reported)The objectives of the study are to determine the impact of interferon-free treatment for the hepatitis C virus (HCV) on peripheral blood immune cell phenotype and soluble immune-related proteins in blood, while controlling for genetic polymorphisms known to impact HCV-related immune responses, and to determine the impact of the therapy on the emergence of drug-resistant HCV. The study design is informed by the researchers recent investigations of patients receiving HCV treatment. About 4% of patients who had not undergone liver transplantation experienced hepatic decompensating or another serious event. There were several cases of bacterial infection and two cases with elevated markers of autoimmune processes. These events suggest that treatment altered immune responses. About 25% of patients who had undergone liver transplantation experienced hepatic decompensating or another serious adverse event. The long term goal is to understand the pathophysiology of these complications and determine whether HCV treatment can cause an immune reconstitution syndrome in susceptible patients, while improving antimicrobial defenses in others
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 11, 2017
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.
January 2015
Actual (reported)March 18, 2016
Actual (reported)March 24, 2016
Actual (reported)December 11, 2017
Actual (reported)December 11, 2017
Actual (reported)cytometry time of flight (CyTOF)
the profile of immune cells in blood as assessed by cytometry time of flight (CyTOF) multiparameter analysis
up to week 14
CD8 T cells
Baseline and week 14
HCV resistance mutations
up to week 14
Patients will be identified by their health care providers, including the co-investigators, who will describe the study to potential participants and inform the research team of patients who are interested in participating.
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Andrea D. Branch, PhD
Icahn School of Medicine at Mount Sinai
74 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2016
First Posted
March 24, 2016
Study Start
January 2015
Actual (reported)Hepatitis C Treatment in Probation and Parole Office
Contact the study team to confirm eligibility.
Primary Completion
December 11, 2017
Actual (reported)Study Completion
December 11, 2017
Actual (reported)Last Updated
January 18, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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