A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
Completed · Phase 2
Conditions studied: Hepatitis B
In brief
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.
Key facts
- Study ID
- NCT04585789
- Run by
- Janssen Research & Development, LLC
- People needed
- 24
- Starts
- 2021-03-11
- Expected to finish
- 2024-01-09
- Last updated by the study team
- 2025-05-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
- 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)
- Presence of hemoglobinopathy (including sickle cell disease, thalassemia)
- Liver biopsy performed prior to screening that led to complications and that in the opinion of the investigator would prohibit another liver biopsy
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States
- UZ Antwerpen — Edegem, Belgium
- Toronto General Hospital — Toronto, Ontario, Canada
- Hopital Beaujon — Clichy, France
- University Medical Center — Hamburg, Germany
- Irccs Ospedale Maggiore Di Milano — Milan, Italy
- New Zealand Clinical Research — Auckland, New Zealand
- ID Clinic — Mysłowice, Poland
- Grahame Hayton Unit — London, United Kingdom
- Kings College Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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