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New drug combo aims to free hepatitis b patients from daily pills

NCT ID NCT07135349

Disease control Sponsor: Shanghai Argo Biopharmaceutical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 2 trial tests whether a new injection called BW-20507, combined with pegylated interferon alfa, can help people with chronic hepatitis B stop their daily antiviral medication (NUCs). About 209 adults with hepatitis B will receive the combination for 48 weeks. The main goal is to see how many can safely stop NUCs by week 72.

What this could mean

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

Active substance
BW-20507 injection combined with pegylated interferon alfa
What this could lead to
If successful, this combination could help some patients with chronic hepatitis B stop taking daily antiviral pills (NUCs) while keeping the virus under control.
What could go wrong
This is an early-phase (Phase 2) trial with only 209 participants, so results may not apply to all patients. The treatment involves injections over 48 weeks and may cause side effects like flu-like symptoms from interferon.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

209 people

The number who actually took part.

Started

Sep 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

16 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: * Participants must sign ICF and are able to complete the procedures as planned for this study. * Males or females aged 18 to 65 (inclusive) when signing informed consent * Body mass index (BMI) arranges 18.5 to 32.0 kg/m2 (inclusive) * Participants must be diagnosed with chronic hepatitis B infection: HBsAg positivity at least 6 months (need documents) * NUC treatment history and screening status of HBV DNA, HBeAg, HBsAg, and ALT must meet the requirements for different cohorts. * Males of reproductive potential or females of childbearing potential must agree to utilize reliable contraception, refrain from childbearing plan, and will not donate sperm or eggs during the study Exclusion Criteria: * Clinically significant abnormalities * Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \> 9.0 kPa * Concomitant clinically significant other liver diseases * Previous/current manifestations of hepatic decompensation * History of acute or chronic renal insufficiency * Significant abnormal ECG at screening * Participants with a history of malignancy or who are being evaluated for a possible malignancy * Serious mental illness or history * Thyroid dysfunction or DM * Suspected history of allergy to any component of the study drug * Those who are participating in another clinical study, or have not undergone a protocol-specified washout period prior to this study * Protocol-specified prohibited therapies usage * Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug * Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study

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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

  • Argo Investigative Site

    Hefei, Anhui, 230022, China

  • Argo Investigative Site

    Beijing, Beijing Municipality, 100015, China

  • Argo Investigative Site

    Sichuan, Chengdu, China

  • Argo Investigative Site

    Chongqing, Chongqing Municipality, 400000, China

  • Argo Investigative Site

    Chongqing, Chongqing Municipality, China

  • Argo Investigative Site

    Fuzhou, Fujian, 350000, China

  • Argo Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Argo Investigative Site

    Shenzhen, Guangdong, 518000, China

  • Argo Investigative Site

    Zunyi, Guizhou, 563000, China

  • Argo Investigative Site

    Changzhou, Jiangsu, 213000, China

  • Argo Investigative Site

    Xuzhou, Jiangsu, 22100, China

  • Argo Investigative Site

    Nanchang, Jiangxi, 330000, China

  • Argo Investigative Site

    Jiangxi, Nanchang, China

  • Argo Investigative Site

    Shanghai, Shanghai Municipality, 2000001, China

  • Argo Investigative Site

    Chengdu, Sichaun, 610041, China

  • Argo Investigative Site

    Chengdu, Sichuan, 610041, China

  • Argo Investigative Site

    Zhejiang, Wenzhou, China

  • Argo Investigative Site

    Hangzhou, Zhejiang, 310000, China

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