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New cocktail of drugs shows promise in hepatitis b trial

NCT ID NCT04225715

Disease control Sponsor: Hoffmann-La Roche 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested several new drug combinations in 281 people with chronic hepatitis B who were already on standard antiviral therapy. The goal was to see if adding experimental drugs could clear a key virus marker (HBsAg) from the blood. Participants received different combinations of oral and injected medications for up to 48 weeks, then were followed for another 48 weeks. The trial aimed to find safer and more effective ways to control the virus.

What this could mean

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

Active substance
Combination of nucleoside analog (NUC), CpAM (Linvencorvir), TLR7 agonist (Ruzotolimod), siRNA (Xalnesiran), PEG-IFN (Pegasys), and PD-L1 LNA (Cadapersen)
What this could lead to
If successful, these combinations could help more people with chronic hepatitis B achieve a functional cure, meaning the virus is suppressed without lifelong medication.
What could go wrong
This is an early phase 2 trial with a small number of participants. The results may not apply to everyone, and some combinations may cause side effects or fail to show lasting benefit.

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

281 people

The number who actually took part.

Started

Jul 2020

Finished

Jul 2024

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

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: * Body mass index between 18 and 32 kg/m2 inclusive. * Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for \>=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for \>=12 months, having received the same NUC therapy for \>=3 months prior to screening. * HBV DNA below the lower LLOQ or \< 20 IU/mL for \> 6 months prior to screening and confirmed at screening. * Alanine transaminase (ALT) \<=1.5 x upper limit of normal (ULN) for \> 6 months prior to screening and confirmed at screening. * Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods. * Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm. Exclusion Criteria: * Pregnant or lactating women. * Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV). * History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease. * History of or suspicion of Hepatocellular Carcinoma (HCC). * Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests. * Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study. * Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study. * History of alcohol abuse and/or drug abuse within one year of randomization. * History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment. * Currently taking, or have received within 3 months of Day 1, systemic corticosteroids. * Electrocardiogram (ECG) with clinically significant abnormalities. * Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.

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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.

Hepatitis B, chronic

Contacts and locations

Locations

  • Asan Medical Center / Clinical Trial Center

    Seoul, 138-736, South Korea

  • Auckland Clinical Studies Limited

    Auckland, 1010, New Zealand

  • Beijing Friendship Hospital

    Beijing, 100050, China

  • Changhua Christian Hospital

    Chang-hua, 500, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chuncheon Sacred Heart Hospital

    Gangwon-Do, 200-704, South Korea

  • HIVNAT

    Bangkok, 10330, Thailand

  • Hopital Beaujon

    Clichy, 92118, France

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36212, Spain

  • Hospital San Juan de Dios La Serena

    La Serena, 1700000, Chile

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • King College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • Middlemore Clinical Trials

    Auckland, New Zealand

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515, China

  • National Cheng Kung Univ Hosp

    Tainan, 00704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025, China

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707, South Korea

  • Seoul National University College of Medicine, Liver Research Institute

    Seoul, South Korea

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006, Romania

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • Tokuda Hospital Sofia

    Sofia, 1407, Bulgaria

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1, Canada

  • Uni of Alberta Hospital

    Edmonton, Alberta, T6G 2S2, Canada

  • University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD

    Sofia, 1431, Bulgaria

  • University of Calgary

    Calgary, Alberta, T2N 2T9, Canada

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

More trials for these conditions

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