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NCT04585789CompletedPhase 2

A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

A Phase 2 Randomized, Open-label, Parallel-group, Multicenter Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Response to Combination Regimens Containing JNJ-73763989 and Nucleos(t)Ide Analog With or Without JNJ-56136379 in Patients With Chronic Hepatitis B Virus Infection

Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
24 (actual)
First submitted
9 Oct 2020
Start date
11 Mar 2021
Primary completion date
8 Feb 2023
Lead sponsor
Janssen Research & Development, LLC
Diseases
Hepatitis B
NCT number
NCT04585789
EudraCT number
2019-004475-39

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 24
  • From 11 Mar 2021 to the primary completion date, 8 Feb 2023
  • 10 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History or signs of cirrhosis or portal hypertension, signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening
  • Liver biopsy performed prior to screening that led to complications and that in the opinion of the investigator would prohibit another liver biopsy

Other illness

  • Evidence of infection with hepatitis A, C, D 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
  • Presence of hemoglobinopathy (including sickle cell disease, thalassemia)

Lab values

  • Presence of coagulopathy or bleeding disorder as indicated by: (a) International normalized ratio (INR) greater than or equal to (\>=) 1.1\* upper limit of normal (ULN); (b) Partial thromboplastin time \>1.1\*ULN; (c) Any signs of prolonged bleeding (\>10 minutes)

Who the study is looking for

  • Medically stable on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiogram (ECG) performed at screening
  • Hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening: participants be either currently not treated with HBeAg positive status or virologically (nucleos\[t\]ide analog \[NA\]) suppressed with HBeAg negative status
  • Hepatitis B surface antigen (HBsAg) greater than (\>) 100 International Units per Milliliter (IU/mL) at screening
  • 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
  • Fibroscan liver stiffness measurement less than and equal to (\<=) 9 Kilopascal (kPa) within 6 months prior to screening or at the time of screening

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Antwerpen
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EdegemBelgiumUnknown status
Toronto General Hospital
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TorontoCanadaUnknown status
University Medical Center
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HamburgGermanyUnknown status
Hopital Beaujon
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ClichyFranceUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Grahame Hayton Unit
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LondonUnited KingdomUnknown status
Irccs Ospedale Maggiore Di Milano
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MilanItalyUnknown status
New Zealand Clinical Research
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AucklandNew ZealandUnknown status
ID Clinic
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MysłowicePolandUnknown status
Johns Hopkins University
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BaltimoreUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.