Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02995252
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2016-12-13
Brief Title:
The HOPE Study Characterizing Patients With Hepatitis B and C
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
An Omnibus Protocol to Characterize Patients With Hepatitis B and C the HOPE Study With Hepatitis B Treatment Sub-study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational longitudinal prospective study for sample collection and evaluation for future therapy or disease progression of chronic hepatitis B and C Participants will be seen on an annual basis with optional additional visits for up to 10 years and provide samples for research and evaluation of disease progression In addition there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of treatment with tenofovir alafenamide and blood collections with optional liver biopsies
Detailed Description:
Hepatitis B virus chronically infects 350 million people worldwide and over one million Americans and approximately 41 million individuals 16 in the US population have been infected with hepatitis C These infections are the leading cause of end-stage liver disease cancer and indication for liver transplantation in the world Both can be transmitted sexually perinatally and percutaneously Coinfected with human immunodeficiency virus HIV accelerates the progression of liver disease and due to shared modes of transmission chronic hepatitis B and C disproportionately affect people living with HIV
The primary objective of this study is to Identify people with viral hepatitis and providing linkage to care and future therapy with evaluation of disease progression as well as characterizing those with hepatitis B and those treated for hepatitis C with directly acting antivirals over the course of 10 years
The study including a participant questionnaire and phlebotomy will be administered on-site at clinical facilities in the District of Columbia and Maryland and at the Institute of Human Virology at the University of Maryland Baltimore The cohort will be designed to study research questions with respect to liver disease disease pathogenesis using genomics proteomics and immunologic disease models Secondary objectives include study of the immunopathogenesis of hepatitis B and C disease progression In addition this is an invaluable opportunity to evaluate the long term effects of hepatitis C clearance with direct acting antivirals along with biomarker profiles for diagnosis and outcome Moreover this will serve as a catchment protocol to select appropriate participants for novel hepatitis B and C therapeutic trials
This study includes a standard-of-care treatment sub-study for patients with hepatitis B In this sub-study participants will receive an approved nucleostide analogue prospectively observed on therapy for change in liver fibrosis
The integrated clinics will provide an optimal environment for the adherence and engagement of medical care and education in decreasing transmission risks of infection The study will establish a blood and specimen repository for participants and include a research database that will be used prospectively to test future hypotheses
The primary objective of this study is to Identify people with viral hepatitis and providing linkage to care and future therapy with evaluation of disease progression as well as characterizing those with hepatitis B and those treated for hepatitis C with directly acting antivirals over the course of 10 years
The study including a participant questionnaire and phlebotomy will be administered on-site at clinical facilities in the District of Columbia and Maryland and at the Institute of Human Virology at the University of Maryland Baltimore The cohort will be designed to study research questions with respect to liver disease disease pathogenesis using genomics proteomics and immunologic disease models Secondary objectives include study of the immunopathogenesis of hepatitis B and C disease progression In addition this is an invaluable opportunity to evaluate the long term effects of hepatitis C clearance with direct acting antivirals along with biomarker profiles for diagnosis and outcome Moreover this will serve as a catchment protocol to select appropriate participants for novel hepatitis B and C therapeutic trials
This study includes a standard-of-care treatment sub-study for patients with hepatitis B In this sub-study participants will receive an approved nucleostide analogue prospectively observed on therapy for change in liver fibrosis
The integrated clinics will provide an optimal environment for the adherence and engagement of medical care and education in decreasing transmission risks of infection The study will establish a blood and specimen repository for participants and include a research database that will be used prospectively to test future hypotheses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None