Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04667104