Impact of Interferon-free Treatment for Hepatitis C Virus (HCV) on Blood Cells and Factors in Blood

NCT02718573 | Completed

• 1 other identifier: GCO 14-2222
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C; HCV; Liver Transplant

Keywords

Hepatitis C; Interferon-free; DDA's

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• CD8 T cells

  Baseline and week 14

• HCV resistance mutations

  up to week 14

Study Arms (2)

Non-liver transplants with HCV

Liver transplants with HCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• All of the above
• At least 6 months post-LT
• On stable immunosuppressive medications for at least 3 months LT only (no other organ transplant, such as kidney)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Andrea D. Branch, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andrea D. Branch PhD

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 24, 2016
• Study Start: January 1, 2015
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)