NCT02995252 The HOPE Study: Characterizing Patients With Hepatitis B and C
| NCT ID | NCT02995252 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Hepatitis B， Chronic |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2014-12 |
| Primary Completion | 2034-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2014-12 with a primary completion date of 2034-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Lydia Tang, MBChB
PRINCIPAL INVESTIGATOR
Institute of Human Virology, University of Maryland School of Medicine
Frequently Asked Questions
Who can join the NCT02995252 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Hepatitis B， Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02995252 currently recruiting?
Yes, NCT02995252 is actively recruiting participants. Contact the research team at LydiaTang@IHV.umaryland.edu for enrollment information.
Where is the NCT02995252 trial being conducted?
This trial is being conducted at Baltimore, United States, Falls Church, United States.
Who is sponsoring the NCT02995252 clinical trial?
NCT02995252 is sponsored by University of Maryland, Baltimore. The principal investigator is Lydia Tang, MBChB at Institute of Human Virology, University of Maryland School of Medicine. The trial plans to enroll 550 participants.