Clinical Trials List
2020-09-01 - 2024-07-05
Phase II
Recruiting4
A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Response-guided Treatment With JNJ-73763989 + JNJ-56136379 + Nucleos(t)Ide Analog Regimen With or Without Pegylated Interferon Alpha-2a in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection and Normal ALT
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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
- 邱彥程 Digestive System Department
- 吳毅晉 Digestive System Department
- Hsin-Yu Kuo 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
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shih-Jer Hsu 無
- Chen-Hua Liu 無
- Chun-Jen Liu 無
- 楊宏志 無
- 曾岱宗 無
- 蘇東弘 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Lung Yu Digestive System Department
- Chia-Yen Dai Digestive System Department
- Jee-Fu Huang Digestive System Department
- 黃駿逸 Digestive System Department
- Chung-Feng Huang Digestive System Department
- 梁博程 Digestive System Department
- Ming-Lun Yeh Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
JNJ-73763989
JNJ-56136379
Dosage Form
injection
tablet
Dosage
200 mg/mL
25 mg
Endpoints
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance up to Week 96 (24 Weeks After Completion of all Study Interventions of Consolidation Phase) Without Restarting NA Treatment [ Time Frame: Up to Week 96 ]
Percentage of participants with HBsAg seroclearance up to week 96 (24 weeks after completion of all study interventions of consolidation phase) without restarting nucleos(t)ide analog (NA) treatment will be reported.
Inclution Criteria
Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening
Currently not treated chronic hepatitis B virus (HBV) infection with normal alanine transaminase (ALT) and HBV deoxyribonucleic acid (DNA) greater than or equal to (≥) 20,000 international units per milliliter (IU/mL)
Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than or equal to (≤) 9 Kilopascal (kPa) at screening
Exclusion Criteria
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 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
Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
Contraindications to the use of PegIFN-α2a
The Estimated Number of Participants
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Taiwan
15 participants
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Global
80 participants
