We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

The HOPE Study: Characterizing Patients With Hepatitis B and C

This study is currently recruiting participants.
Verified April 2017 by Lydia Tang, University of Maryland
Sponsor:
ClinicalTrials.gov Identifier:
NCT02995252
First Posted: December 16, 2016
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lydia Tang, University of Maryland
  Purpose
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.

Condition Intervention
Hepatitis B, Chronic Hepatitis C Other: Blood draws Drug: Tenofovir Alafenamide Other: Knowledge Index Questionnaire Other: Liver transient elastography (FibroScan) Procedure: Liver Biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study

Resource links provided by NLM:


Further study details as provided by Lydia Tang, University of Maryland:

Primary Outcome Measures:
  • Change in liver stiffness among participants with chronic hepatitis B infection [ Time Frame: 2 years ]
    Participants will be provided with the nucleotide analogue, tenofovir alafenamide. Change in liver stiffness as measured by transient elastography (FibroScan) before starting tenofovir alafenamide, at time of liver enzyme normalization, and at 2 years of treatment.


Estimated Enrollment: 550
Study Start Date: December 2014
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: Hepatitis C infection
Participants with chronic hepatitis C infection; includes both hepatitis C mono infected and hepatitis C-HIV coinfected. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. No drugs will be given to this group.
Other: Blood draws Other: Knowledge Index Questionnaire
Group 2: Hepatitis B infection

Participants with chronic hepatitis B: includes patients with hepatitis B with and without hepatitis C and/or HIV. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. Participants who are already taking hepatitis B treatment are eligible.

Hepatitis B treatment sub-study: In this treatment sub-study, participants with hepatitis B monoinfection will receive tenofovir alafenamide (TAF) pill once a day for 2 years with study visits every 3 months. Liver transient elastography will be reviewed or obtained. In addition, approximately 40 participants will be invited to undergo optional liver biopsies at the start, end of year 1 and end of year 2 of the sub-study.

Other: Blood draws Drug: Tenofovir Alafenamide
25 mg tablet, once a day by mouth.
Other: Knowledge Index Questionnaire Other: Liver transient elastography (FibroScan)
Participants of the hepatitis B treatment sub-study may have FibroScans completed at baseline, during the study with liver enzyme normalization, and at the end of the study.
Procedure: Liver Biopsy
40 participants of the hepatitis B treatment sub-study will have liver biopsies prior to starting tenofovir alafenamide, and at years 1 and 2 of receiving treatment.

Detailed Description:

Hepatitis B virus chronically infects 350 million people worldwide and over one million Americans and approximately 4.1 million individuals (1.6%) 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 profile(s) 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 nucleos(t)ide 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People with chronic hepatitis B and/or C, with or without HIV infection. Or people who have cleared hepatitis B infection, or been treated for hepatitis C infection with direct acting antiviral agents.
Criteria

Inclusion Criteria:

  1. At least 18 years old
  2. Hepatitis B and/or C-infected; or history of hepatitis B infection, but cleared; or hepatitis C infection and successfully treated with direct acting antiviral agents, with or without HIV infection; or healthy volunteer without history of HBV and/or C, nor HIV
  3. Willing to have samples stored for future research
  4. Must have an identifiable primary care provider or be in the process of establishing a primary care provider
  5. Willing to undergo HIV testing if not recently documented
  6. Inclusion in the HBV treatment sub-study will be dependent on eligibility to receive nucleos(t)ide analogue therapy according to standard-of-care.

Exclusion Criteria:

  1. Unable to comply with research study visits
  2. Poor venous access not allowing screening laboratory collection
  3. Have any condition that the investigator considers a contraindication to study participation.
  4. HBV monoinfected participants with any contraindications to HBV treatment with nucleos(t)ide analogues will be ineligible to participate in the HBV treatment sub-study.
  5. Pregnant or breastfeeding women will not be eligible to participate in the HBV treatment sub-study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995252


Contacts
Contact: Haley Ward, BS 410 706 6569 HWard@ihv.umaryland.edu
Contact: Joyce Lam, BPH (410) 706-3367 JLam@IHV.umaryland.edu

Locations
United States, District of Columbia
Unity Health Care, Inc./Walker Jones Recruiting
Washington, D.C., District of Columbia, United States, 20002
Contact: Angie Price, CRNP MSN    410-706-1709    aprice@ihv.umaryland.edu   
United States, Maryland
Institute of Human Virology, University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Haley Ward, BS    410-706-6569    hward@ihv.umaryland.edu   
Contact: Joyce Lam, BPH    (410) 706-3367    jlam@ihv.umaryland.edu   
Pan Asian Volunteer Health Clinic at the Chinese Culture and Community Service Center Recruiting
Gaithersburg, Maryland, United States, 20877
Contact: Angie Price, CRNP MSN    410-706-1709    aprice@ihv.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Lydia Tang, MBChB Institute of Human Virology, University of Maryland School of Medicine
  More Information

Responsible Party: Lydia Tang, MD, University of Maryland
ClinicalTrials.gov Identifier: NCT02995252     History of Changes
Other Study ID Numbers: HP-00063191
First Submitted: December 13, 2016
First Posted: December 16, 2016
Last Update Posted: May 2, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Liver Extracts
Tenofovir
Hematinics
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents