RECRUITING

The HOPE Study: Characterizing Patients With Hepatitis B and C

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Conditions

Hepatitis B， ChronicHepatitis C

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study

Quick Facts

Study Start:2014-12
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02995252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At least 18 years old
  2. 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. 3. Willing to have samples stored for future research
  4. 4. Must have an identifiable primary care provider or be in the process of establishing a primary care provider
  5. 5. Willing to undergo HIV testing if not recently documented
  6. 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.
  1. 1. Unable to comply with research study visits
  2. 2. Poor venous access not allowing screening laboratory collection
  3. 3. Have any condition that the investigator considers a contraindication to study participation.
  4. 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. 5. Pregnant or breastfeeding women will not be eligible to participate in the HBV treatment sub-study

Contacts and Locations

Study Contact

Christine Lin, BA
CONTACT
(410) 706-3367
Christine.Lin@IHV.umaryland.edu

Principal Investigator

Lydia Tang, MBChB
PRINCIPAL_INVESTIGATOR
Institute of Human Virology, University of Maryland School of Medicine

Study Locations (Sites)

Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
Dr Huong Dang, Medical Practice
Falls Church, Virginia, 22044
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Lydia Tang, MBChB, PRINCIPAL_INVESTIGATOR, Institute of Human Virology, University of Maryland School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-12
Study Completion Date2025-12

Study Record Updates

Study Start Date2014-12
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Hepatitis B， Chronic
  • Hepatitis C