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New hepatitis b drug shows promise in large trial

NCT ID NCT07203118

Disease control Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medication called hepenofovir fumarate (HTS) for people with chronic hepatitis B, a long-term liver infection. About 1,444 adults aged 18-65 who have not been treated before (or stopped treatment at least 6 months ago) will take one of three doses of HTS or the standard drug TAF daily. The goal is to see which dose works best and is safest, with the hope of offering a new treatment option.

What this could mean

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

Active substance
hepenofovir fumarate (HTS)
What this could lead to
If successful, this could provide a new once-daily pill option to control chronic hepatitis B, potentially with better safety or efficacy than current treatments.
What could go wrong
This is an early-to-mid stage trial, so the drug may not prove more effective or safer than existing therapy. Side effects are still being evaluated.

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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,444 people

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

Started

Jul 2025

Expected to finish

Feb 2030

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.

Ages

18 to 65 years

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: 1）Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology). 3)No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline. 4\) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit. 5\) Willing to use effective non-pharmacological contraception during the trial period. Exclusion Criteria: 1. Hypersensitive to the study drug, its metabolites or any excipient in its formula; 2. With previous or present clinical hepatic decompensation (e.g., ascites, hepatic encephalopathy or varicose vein haemorrhage) 3. Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc. 4. Complicated with HCV, HIV or HDV infections 5. Documented resistance to the antiviral drug (Tenofovir). 6. Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

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

Chronic hepatitis B

Contacts and locations

Locations

  • The First Hospital of Jilin University

    Jilin City, changchun, China

More trials for these conditions

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