Phase 2
Completed N=48
A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT04667104 ↗
Enrolled (actual)
48
Serious AEs
3.5%
Results posted
Jul 2024
Primary outcomePrimary: Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24 — 64.6 percentage of participants
Summary
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 + nucleos[t]ide analog [NA] and pegylated interferon alpha-2a [PegIFN-alpha2a]).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24 |
64.6 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability |
52.1; 87.5; 60.4 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability |
0; 2.1; 8.3 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability |
1; 1; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability |
0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability |
— | — |
| SECONDARY Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI) |
31.3 | — |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs |
36.4; 27.3; 27.3; 90.9; 100.0; 81.8 | — |
| SECONDARY Percentage of Participants With HBsAg Levels Below Different Cut-offs |
0; 2.1; 2.1; 4.2; 6.3; 2.1 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs |
95.8; 75.0; 81.3; 52.1; 27.1; 54.2 | — |
| SECONDARY Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN |
33.3; 33.3; 66.7 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion |
0; 10.0; 20.0 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion |
0; 0; 0 | — |
| SECONDARY Change From Baseline Over Time in HBsAg Levels |
-1.43; -2.18; -0.71 | — |
| SECONDARY Change From Baseline Over Time in HBeAg Levels |
-0.68; -0.72; -0.53 | — |
| SECONDARY Change From Baseline Over Time in HBV DNA Levels |
0.03; 0.28; 0.36 | — |
| SECONDARY Time to First Occurrence of HBsAg Seroclearance |
NA | — |
| SECONDARY Time to First Occurrence of HBeAg Seroclearance |
14.1 | — |
| SECONDARY Time to First Occurrence of HBV DNA < LLOQ |
4.1 | — |
| SECONDARY Percentage of Participants With Virologic Breakthrough |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Seroclearance at Week 48 Without Re-starting NA Treatment |
— | — |
| SECONDARY Percentage of Participants With HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment |
30.0 | — |
| SECONDARY Percentage of Participants With Biochemical Flares |
0; 4.2; 0; 0 | — |
| SECONDARY Percentage of Participants With Virologic Flares |
33.3 | — |
| SECONDARY Number of Participants Requiring NA Re-treatment |
4 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) |
1338; 928; 271; 185 | — |
| SECONDARY Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) |
309; 390; 38.7; 57.4 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) |
5.50; 6.00; 2.00; 4.02 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) |
18635; 13580; 3342; 2466 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis B virus (HBV) infection, hepatitis B e Antigen (HBeAg) positive or negative with suppressed viral replication under nucleos(t)ide analogue treatment for at least 6 months prior to screening
- Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
- Must have serum HBsAg greater than (>) 100 international units per milliliter (IU/mL) at screening, as assessed by quantitative HBsAg assay
- Must have a fibroscan stiffness measurement less than or equal to (<=) 9.0 Kilopascal (kPa) at screening
Exclusion Criteria
- Evidence of hepatitis A, C, D or E virus infection or human immunodeficiency, virus type 1 (HIV) or HIV-2 infection at screening
- History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
- Evidence of liver disease of non-HBV etiology
- Participants with a history of malignancy within 5 years before screening
- Contraindications to the use of pegylated interferon alpha-2a
Data sourced from ClinicalTrials.gov (NCT04667104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.