Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 \[...
Detailed Description
This study is an intervention specific appendix to the Hepatitis B wings platform trial (PLATFORMPAHPB2001). The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initiall...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04667104
Start Date
February 1 2021
End Date
April 17 2023
Last Update
July 3 2024
Active Locations (11)
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1
Tokyo Medical and Dental University Hospital
Bunkyō City, Japan, 113 8519
2
Osaka University Hospital
Suita-shi, Japan, 565-0871
3
New Zealand Clinical Research
Auckland, New Zealand, 1010
4
Middlemore Clinical Trials
Papatoetoe, New Zealand, 2025