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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04667104




Registration number
NCT04667104
Ethics application status
Date submitted
9/12/2020
Date registered
14/12/2020
Date last updated
3/07/2024

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2020-003956-34
Secondary ID [2] 0 0
CR108928
Universal Trial Number (UTN)
Trial acronym
PENGUIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-73763989
Treatment: Drugs - Tenofovir disoproxil
Treatment: Drugs - Tenofovir alafenamide (TAF)
Treatment: Drugs - Entecavir (ETV) monohydrate
Treatment: Drugs - PegIFN-alpha2a

Experimental: 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-a2a for 12 weeks during Treatment Period 2.


Treatment: Drugs: JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.

Treatment: Drugs: Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally once daily.

Treatment: Drugs: Tenofovir alafenamide (TAF)
TAF film-coated tablet will be administered orally once daily.

Treatment: Drugs: Entecavir (ETV) monohydrate
ETV monohydrate film-coated tablet will be administered orally once daily.

Treatment: Drugs: PegIFN-alpha2a
PegIFN-alpha2a injection will be administered subcutaneously once weekly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From Baseline (Day 1) to Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
Timepoint [1] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [2] 0 0
Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Timepoint [2] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [3] 0 0
Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability
Timepoint [3] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [4] 0 0
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Timepoint [4] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [5] 0 0
Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability
Timepoint [5] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to Week 28
Secondary outcome [6] 0 0
Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability
Timepoint [6] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24
Secondary outcome [7] 0 0
Number of Participants With Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability
Timepoint [7] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24
Secondary outcome [8] 0 0
Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI)
Timepoint [8] 0 0
At Week 24 (EOSI)
Secondary outcome [9] 0 0
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs
Timepoint [9] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [10] 0 0
Percentage of Participants With HBsAg Levels Below Different Cut-offs
Timepoint [10] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [11] 0 0
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
Timepoint [11] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [12] 0 0
Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN
Timepoint [12] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [13] 0 0
Percentage of Participants With HBeAg Seroconversion
Timepoint [13] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [14] 0 0
Percentage of Participants With HBsAg Seroconversion
Timepoint [14] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [15] 0 0
Change From Baseline Over Time in HBsAg Levels
Timepoint [15] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [16] 0 0
Change From Baseline Over Time in HBeAg Levels
Timepoint [16] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [17] 0 0
Change From Baseline Over Time in HBV DNA Levels
Timepoint [17] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [18] 0 0
Time to First Occurrence of HBsAg Seroclearance
Timepoint [18] 0 0
From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [19] 0 0
Time to First Occurrence of HBeAg Seroclearance
Timepoint [19] 0 0
From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [20] 0 0
Time to First Occurrence of HBV DNA < LLOQ
Timepoint [20] 0 0
From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [21] 0 0
Percentage of Participants With Virologic Breakthrough
Timepoint [21] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [22] 0 0
Percentage of Participants With HBsAg Seroclearance at Week 48 Without Re-starting NA Treatment
Timepoint [22] 0 0
At Week 48 (24 weeks after completion of all study interventions at Week 24)
Secondary outcome [23] 0 0
Percentage of Participants With HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment
Timepoint [23] 0 0
At Week 48 (24 weeks after completion of all study interventions at Week 24)
Secondary outcome [24] 0 0
Percentage of Participants With Biochemical Flares
Timepoint [24] 0 0
Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [25] 0 0
Percentage of Participants With Virologic Flares
Timepoint [25] 0 0
Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [26] 0 0
Number of Participants Requiring NA Re-treatment
Timepoint [26] 0 0
Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Secondary outcome [27] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
Timepoint [27] 0 0
Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12
Secondary outcome [28] 0 0
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
Timepoint [28] 0 0
Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12
Secondary outcome [29] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
Timepoint [29] 0 0
Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12
Secondary outcome [30] 0 0
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)
Timepoint [30] 0 0
Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2023
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Bunkyo Ku
Country [2] 0 0
Japan
State/province [2] 0 0
Suita-shi
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Papatoetoe
Country [5] 0 0
Poland
State/province [5] 0 0
Gdansk
Country [6] 0 0
Poland
State/province [6] 0 0
Myslowice
Country [7] 0 0
Poland
State/province [7] 0 0
Warszawa
Country [8] 0 0
Poland
State/province [8] 0 0
Wroclaw
Country [9] 0 0
Taiwan
State/province [9] 0 0
Kaohsiung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taichung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Tainan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 \[NA\] and pegylated interferon alpha-2a \[PegIFN-alpha2a\]).
Trial website
https://clinicaltrials.gov/study/NCT04667104
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04667104