Clinical Trials List
Protocol Number73763989PAHPB2006
NCT Number(ClinicalTrials.gov Identfier)NCT04667104
Completed
2021-01-18 - 2023-08-31
Phase II
Recruiting3
A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
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Trial Applicant
Johnson & Johnson
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 吳毅晉 Digestive System Department
- Hsin-Yu Kuo Digestive System Department
- 邱彥程 Digestive System Department
- 簡世杰 Digestive System Department
- Chiu Hung Chiu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jee-Fu Huang 無
- Ming-Lun Yeh 無
- Chung-Feng Huang 無
- 梁博程 無
- Chia-Yen Dai 無
- Ming-Lung Yu 無
- 黃駿逸 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Objectives
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].
Test Drug
JNJ-73763989
JNJ-56136379
JNJ-56136379
JNJ-56136379
JNJ-56136379
Active Ingredient
JNJ-73763989
JNJ-56136379
JNJ-56136379
JNJ-56136379
JNJ-56136379
Dosage Form
Injection
Tablets
Tablets
Tablets
Tablets
Dosage
200 mg/mL
100 mg
25 mg
100 mg
25 mg
Endpoints
Percentage of Participants with a Reduction of at Least 2 log10 IU/mL in Hepatitis B Surface Antigen (HBsAg) Levels
Inclution Criteria
1.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
2.Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
3.Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
4.Must have serum HBsAg greater than (>) 100 international units per milliliter (IU/mL) at screening, as assessed by quantitative HBsAg assay
5.Must have a fibroscan stiffness measurement less than or equal to (<=) 9.0 Kilopascal (kPa) at screening
2.Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
3.Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
4.Must have serum HBsAg greater than (>) 100 international units per milliliter (IU/mL) at screening, as assessed by quantitative HBsAg assay
5.Must have a fibroscan stiffness measurement less than or equal to (<=) 9.0 Kilopascal (kPa) at screening
Exclusion Criteria
1.Evidence of hepatitis A, C, D or E virus infection or human immunodeficiency, virus type 1 (HIV) or HIV-2 infection 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.Evidence of liver disease of non-HBV etiology
4.Participants with a history of malignancy within 5 years before screening
5.Contraindications to the use of pegylated interferon alpha-2a
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.Evidence of liver disease of non-HBV etiology
4.Participants with a history of malignancy within 5 years before screening
5.Contraindications to the use of pegylated interferon alpha-2a
The Estimated Number of Participants
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Taiwan
25 participants
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Global
50 participants
