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Can a new shot help control hepatitis d in people with hepatitis b?

NCT ID NCT04535544

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding an experimental drug called JNJ-73763989 to standard oral antivirals can better suppress hepatitis D virus in people who are also infected with hepatitis B. About 52 adults with stable chronic co-infection will receive either the combination or a placebo plus antivirals. The goal is to see if the added drug leads to a significant drop in hepatitis D levels and improves liver enzyme readings.

What this could mean

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

Active substance
an experimental drug called JNJ-73763989 (JNJ-3989) given as a shot, plus standard oral antivirals (entecavir, tenofovir disoproxil, or tenofovir alafenamide)
What this could lead to
If successful, this combination could offer a more effective way to suppress hepatitis D virus and improve liver health in people with chronic co-infection.
What could go wrong
This is a mid-stage trial with only 52 participants, so results may not apply broadly. The experimental drug is injected and may cause side effects, and it is unclear if it will outperform standard therapy alone.

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

52 people

The number who actually took part.

Started

Sep 2020

Finished

Mar 2025

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: * Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening * Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening * For Part 1: hepatitis D RNA (HDV RNA) greater than or equal to (\>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values \>= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (\<=) 10000 IU/mL at screening or HDV RNA values at screening are \<= 100000 IU/mL * Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN) * Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included * Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential * Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of \>= 140000 per deciliter (dL) for enrollment into Part-2 Exclusion Criteria: * Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening * History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol * Evidence of liver disease of non-HBV/HDV etiology * Signs of hepatocellular carcinoma (HCC) * Significant laboratory abnormalities as defined in the protocol at screening * Participants with a history of malignancy within 5 years before screening * Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol * History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease * Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant * History of or current clinically significant skin disease or drug rash * Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients or excipients of the placebo content * Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information * Participants who have taken any therapies disallowed per protocol * Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention * Male participants who plan to father a child while enrolled * Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant * Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection hepatitis D virus infection Hepatitis D, Chronic

As listed by the trial registrant

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

Hepatitis D, chronic

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124, Italy

  • Beijing Ditan Hospital Capical Medical University

    Beijing, 100015, China

  • CHU Hopital Saint Antoine

    Paris, 75012, France

  • CHU de Nantes hotel Dieu

    Nantes, 44093, France

  • Centro Oncológico De Roraima

    Boa Vista, 69304015, Brazil

  • Cepem - Centro de Pesquisa Em Medicina Tropical

    Porto Velho, 76812-329, Brazil

  • China Medical University Hospital

    Tiachung, Taiwan

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35033, France

  • Danderyds Sjukhus

    Danderyd, 18288, Sweden

  • Ege University Medical of Faculty, Department of Gastroenterology

    Izmir, 35100, Turkey (Türkiye)

  • Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado

    Manaus, 69040-000, Brazil

  • Guangzhou Eighth People's Hospital, Guangzhou Medical University

    Guangzhou, 510000, China

  • Harvard Medical School Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619, Japan

  • Hopital Beaujon

    Clichy, 92110, France

  • Hopital de La Croix Rousse

    Lyon, 69004, France

  • Hosp Clinic de Barcelona

    Barcelona, 8028, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Ikeda City Hospital

    Ikeda, 563-8510, Japan

  • Irccs Ospedale Maggiore Di Milano

    Milan, 20122, Italy

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Karadeniz Teknik University Medical Faculty

    Trabzon, 61080, Turkey (Türkiye)

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 14186, Sweden

  • Kings College Hospital

    London, SE5 9RF, United Kingdom

  • Kocaeli University Medical Faculty

    Kocaeli, 41001, Turkey (Türkiye)

  • Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis

    Krasnoyarsk, 660049, Russia

  • Kumamoto Shinto General Hospital

    Kumamoto, 862 8655, Japan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Medical Company Hepatolog Ltd

    Samara, 443045, Russia

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • Nakagami Hospital

    Okinawa, 904-2195, Japan

  • Nanfang Hospital

    Guangzhou, 510515, China

  • National Hospital Organization Nagasaki Medical Center

    Nagasaki, 856-8562, Japan

  • National Hospital Organization Shikoku Cancer Center

    Iizuka-shi, 820-8505, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • New Zealand Clinical Research

    Auckland, 1010, New Zealand

  • Osaka University Hospital

    Suita-shi, 565-0871, Japan

  • Ospedale Molinette, AO Città della Salute e della Scienza di

    Torino, 10126, Italy

  • Peking University People s Hospital

    Beijing, 100044, China

  • Royal Prince Alfred Hospital

    Camperdown, 2050, Australia

  • Skanes universitetssjukhus

    Malmö, 20502, Sweden

  • St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

    Saint Petersburg, 190103, Russia

  • Stanford University School of Medicine

    Redwood City, California, 94063, United States

  • Suita Municipal Hospital

    Suita, 564-8567, Japan

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003, China

  • The First Bethune Hospital of Jilin University

    Changchun, 130021, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010, China

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113 8519, Japan

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575, Japan

  • Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

    Rome, 00161, Italy

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • University of the Ryukyus Hospital

    Nakagami Gun, 903-0215, Japan

  • Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

    Frankfurt, 60590, Germany

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • Western Health

    Footscray, 3011, Australia

  • Westmead Hospital

    Westmead, 2145, Australia

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