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Tiny study hopes antiviral drug eases dangerous liver pressure

NCT ID NCT04863703

Knowledge-focused Sponsor: Hannover Medical School 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This observational study follows 11 patients with chronic hepatitis B and delta coinfection and liver cirrhosis who are already receiving the antiviral drug Bulevirtide. Researchers want to see if suppressing the virus reduces portal hypertension—a dangerous buildup of pressure in the liver's blood vessels. They will measure pressure changes and quality of life over time.

What this could mean

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

Active substance
Bulevirtide
What this could lead to
If successful, this study could show that viral suppression with Bulevirtide lowers portal hypertension, potentially improving outcomes for patients with hepatitis delta and cirrhosis.
What could go wrong
This is a very small observational study (11 participants) with no control group, so results may not be generalizable. It only measures changes in pressure, not long-term clinical benefits.

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 11 people

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

Started

May 2021

Expected to finish

Dec 2026

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

The study populations consists out of patients with HBV/HDV coinfection, diagnosed or suspected liver cirrhosis. All patients must have a medical indication for HVPG measurement or had a HVPG measurement within the last 12 months.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Chronic HBV/HDV Coinfection * suspected or diagnosed liver cirrhosis, indication for hepatovenous pressure gradient (HVPG) measurement or liver cirrhosis and HVPG measurement conducted in the past 12 months (conducted prior to antiviral treatment) * indication for antiviral treatment with Bulevirtide * age \>18years * Must be willing to participate in the study and provide written informed consent Exclusion Criteria: * patient rejects study participation * no conducted or no indication for HVPG measurement * age \<18years

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hepatitis B virus infection hepatitis D virus infection portal hypertension

As listed by the trial registrant

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

Hepatitis B Hepatitis D Liver cirrhosis Portal hypertension

Contacts and locations

Locations

  • Hannover Medical School

    Hanover, Lower Saxony, 30625, Germany

More trials for these conditions

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