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
NCT ID: NCT04667104
Last Updated: 2024-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2021-02-01
2023-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)
Participants will receive combination treatment with JNJ-73763989+ nucleos(t)ide analog (NA) for 12 weeks during Treatment Period 1 and the participants who meet the eligibility criteria for PegIFN-alpha2a at Week 12 will receive combination treatment with JNJ-73763989 + NA plus PegIFN-α2a for 12 weeks during Treatment Period 2.
JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
Tenofovir alafenamide (TAF)
TAF film-coated tablet will be administered orally once daily.
Entecavir (ETV) monohydrate
ETV monohydrate film-coated tablet will be administered orally once daily.
PegIFN-alpha2a
PegIFN-alpha2a injection will be administered subcutaneously once weekly.
Interventions
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JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
Tenofovir alafenamide (TAF)
TAF film-coated tablet will be administered orally once daily.
Entecavir (ETV) monohydrate
ETV monohydrate film-coated tablet will be administered orally once daily.
PegIFN-alpha2a
PegIFN-alpha2a injection will be administered subcutaneously once weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Tokyo Medical and Dental University Hospital
Bunkyō City, , Japan
Osaka University Hospital
Suita-shi, , Japan
New Zealand Clinical Research
Auckland, , New Zealand
Middlemore Clinical Trials
Papatoetoe, , New Zealand
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
Gdansk, , Poland
ID Clinic
Mysłowice, , Poland
Wojewodzki Szpital Zakazny w Warszawie
Warsaw, , Poland
Przychodnia EuroMediCare Wroclaw Lowiecka
Wroclaw, , Poland
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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References
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Gane E, Janczewska E, Takehara T, Chuang WL, Peng CY, Hlebowicz M, Asahina Y, Chang TT, Kalmeijer R, Jezorwski J, Kim G, Anastasiou Z, Kakuda TN, Verbinnen T, Pehlivanov N, Bakala A, Lenz O, Biermer M. Peginterferon-alpha-2a add-on to treatment with siRNA JNJ-73763989 in virologically suppressed chronic hepatitis B: The phase II PENGUIN study. JHEP Rep. 2025 Jul 9;7(10):101516. doi: 10.1016/j.jhepr.2025.101516. eCollection 2025 Oct.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-003956-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
73763989PAHPB2006
Identifier Type: OTHER
Identifier Source: secondary_id
CR108928
Identifier Type: -
Identifier Source: org_study_id
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