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10-Year hepatitis study aims to unlock secrets of liver disease

NCT ID NCT02995252

Knowledge-focused Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study follows people with chronic hepatitis B or C for up to 10 years to track how the disease changes over time. A smaller group with hepatitis B will receive the drug tenofovir alafenamide for 2 years to see if it reduces liver stiffness. Participants provide blood samples and may have optional liver biopsies or FibroScans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tenofovir alafenamide
What this could lead to
If successful, this could help doctors better understand how hepatitis B and C progress over time and whether tenofovir alafenamide can reduce liver stiffness.
What could go wrong
This is an observational study with a small treatment sub-study, so results may not apply to everyone. The treatment may not improve liver health for all participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Dec 2014

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection hepatitis C virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B, chronic Hepatitis C

Contacts and locations

Locations

  • Dr Huong Dang, Medical Practice

    Falls Church, Virginia, 22044, United States

  • Institute of Human Virology, University of Maryland School of Medicine

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.