An efficacy and safety study of a combination of JNJ-73763989, nucleos(t)ide analogs (NA), and a programmed cell death protein receptor-1 (PD-1) inhibitor in chronic hepatitis B participants

A phase 2 open-label trial to evaluate safety, efficacy, tolerability, and pharmacodynamics of a combination of JNJ-73763989, nucleos(t)ide analogs, and a PD-1 inhibitor in chronic hepatitis B patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15803686

Enrollment

Registered

2022-05-24

Start date

2022-05-25

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B Virus Infection Infections and Infestations

Interventions

The total duration of the study is 76 – 80 weeks which includes a screening period, a treatment period and a follow-up period. Participants will be randomly assigned to one of two treatment arms by an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants must have chronic hepatitis B virus (HBV) infection 2. Participants must have fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (KpA) or a liver biopsy result classified as metavir F0-F2

Exclusion criteria

Exclusion criteria: 1. Participants with evidence of hepatitis A virus infection (hepatitis A antibody immunoglobulin IgM), hepatitis C virus (HCV) infection (HCV antibody), hepatitis D virus (HDV) infection (HDV antibody), hepatitis E virus (HEV) infection (Hepatitis E antibody IgM) or human immunodeficiency virus type-1 (HIV-1) or human immunodeficiency virus type-2 (HIV-2) infection (laboratory confirmed) at screening 2. History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices 3. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities 4. Participants with personal/familial history/indicative of immune-mediated disease risk

Design outcomes

Primary

Measure	Time frame
Percentage of Participants who Achieve Hepatitis B Surface Antigen (HBsAg) Seroclearance determined at follow up week 24.	—

Secondary

Measure	Time frame
1. Percentage of Participants who Experience Adverse Events (AEs) of Interest, monitored up to week 72. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. AEs of interest are significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals. 2. Number of Participants with Adverse Events (AEs) by Severity, monitored up to week 72. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of adverse event will be graded by using Division of AIDS (DAIDS) grading scale ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, Grade 5 indicates death. 3. Number of Participants with Immune Related Adverse Events (AEs) by Severity, monitored up to week 72. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of immune related AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. 4. Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Clinical Laboratory Tests, 12-lead Electrocardiograms (ECGs), monitored up to week 72. Number of participants with abnormalities in vital sign measurements (including pulse rate and blood pressure, both syst	—

Measure

Time frame

1. Percentage of Participants who Experience Adverse Events (AEs) of Interest, monitored up to week 72. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. AEs of interest are significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals. 2. Number of Participants with Adverse Events (AEs) by Severity, monitored up to week 72. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of adverse event will be graded by using Division of AIDS (DAIDS) grading scale ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, Grade 5 indicates death. 3. Number of Participants with Immune Related Adverse Events (AEs) by Severity, monitored up to week 72. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of immune related AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. 4. Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Clinical Laboratory Tests, 12-lead Electrocardiograms (ECGs), monitored up to week 72. Number of participants with abnormalities in vital sign measurements (including pulse rate and blood pressure, both syst

—

Countries

Canada, Czech Republic, England, France, Italy, Malaysia, Russian Federation, Scotland, Spain, Taiwan, Turkey, United Kingdom

Contacts

Public ContactLouise Smith

JanssenUKRegistryQueries@its.jnj.com-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026