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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 (PENGUIN)

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ClinicalTrials.gov Identifier: NCT04667104
Recruitment Status : Completed
First Posted : December 14, 2020
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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]).

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: JNJ-73763989 Drug: Tenofovir disoproxil Drug: Tenofovir alafenamide (TAF) Drug: Entecavir (ETV) monohydrate Drug: PegIFN-alpha2a Phase 2

Detailed Description:
This study is an intervention specific appendix to the Hepatitis B wings platform trial (PLATFORMPAHPB2001). The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initially part of the study intervention but has been removed as part of amendment 3 of the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : May 16, 2022
Actual Study Completion Date : April 17, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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-α2a for 12 weeks during Treatment Period 2.
 Drug: JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
Other Name: JNJ-3989

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

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

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

Drug: PegIFN-alpha2a
PegIFN-alpha2a injection will be administered subcutaneously once weekly.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with a Reduction of at Least 2 log10 IU/mL in Hepatitis B Surface Antigen (HBsAg) Levels [ Time Frame: From Baseline up to Week 24 (end of study intervention) ]
    Percentage of participants with a reduction of at least 2 log10 international units per milliliter (IU/mL) in HBsAg levels from baseline to Week 24 will be reported.


Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Up to Week 72 ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  2. Number of Participants with Abnormalities in Vital Signs and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability [ Time Frame: Up to Week 72 ]
    Number of participants with abnormalities in vital signs and clinically significant laboratory findings will be reported.

  3. Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECGs) [ Time Frame: Up to Week 28 ]
    Percentage of participants with abnormalities (heart rate, PR, QRS and QT corrected [QTc]) in 12- lead ECGs will be reported.

  4. Number of Participants with Abnormalities in Ophthalmic and Physical Examination as a Measure of Safety and Tolerability [ Time Frame: Up to Week 24 ]
    Number of participants with abnormalities in ophthalmic and physical examination will be reported.

  5. Percentage of Participants Meeting the Protocol-defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI) [ Time Frame: Up to Week 72 ]
    Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI will be reported.

  6. Percentage of Participants with Hepatitis B e Antigen (HBeAg), HBsAg, and Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) and ALT Levels [ Time Frame: Up to Week 72 ]
    Percentage of participants with HBeAg, HBsAg, and HBV DNA levels and alanine aminotransferase (ALT) levels below/above different cut-offs will be reported.

  7. Percentage of Participants with HBsAg and HBeAg Seroconversion [ Time Frame: Up to Week 72 ]
    Percentage of participants with HBsAg and HBeAg seroconversion (Unit: International units per milliliter) will be reported.

  8. Change from Baseline Over Time in HBsAg, HBeAg and HBV DNA Levels [ Time Frame: Baseline, Up to Week 72 ]
    Change from baseline over time in HBsAg, HBeAg and HBV DNA levels (Unit: International units per milliliter) will be reported.

  9. Time to Achieve HBsAg, HBeAg and HBV DNA Levels Seroclearance/Seroconversion [ Time Frame: Up to Week 72 ]
    Time to achieve HBsAg, HBeAg and HBV DNA levels seroclearance/seroconversion (Unit: International units per milliliter) will be reported.

  10. Percentage of Participants with Virologic Breakthrough [ Time Frame: Up to Week 72 ]
    Percentage of participants with virologic breakthrough will be reported.

  11. Percentage of Participants with HBV DNA < LLOQ [ Time Frame: At Week 48 ]
    Percentage of participants with HBV DNA < LLOQ will be reported.

  12. Percentage of Participants with Virologic and/or Biochemical Flares [ Time Frame: Up to Week 72 ]
    Percentage of participants with virologic and/or biochemical flares will be reported.

  13. Percentage of Participants Requiring NA Re-treatment [ Time Frame: Up to Week 72 ]
    Percentage of participants requiring NA re-treatment based on failure in NA treatment completion criteria will be reported.

  14. Serum Concentration of of JNJ-3989 [ Time Frame: Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141) ]
    Serum samples will be analyzed to determine concentrations of JNJ-3989.

  15. Serum Concentration of JNJ-6379 (Optional) [ Time Frame: Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141) ]
    Serum samples will be analyzed to determine concentrations of JNJ-6379.

  16. Serum Concentration of Nucleos(t)ide Analog (Optional) [ Time Frame: Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141) ]
    Serum samples will be analyzed to determine concentrations of nucleos(t)ide analog.

  17. Serum Concentration of PegIFN-alpha2a (Optional) [ Time Frame: Predose and 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hour, 8 hours,10 hours, and 24 hours post dose (on day 29 and 141) ]
    Serum samples will be analyzed to determine concentrations of PegIFN-alpha2.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667104


Locations
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Japan
Tokyo Medical and Dental University Hospital
Bunkyo-Ku, Japan, 113-8519
Osaka University Hospital
Suita-shi, Japan, 565-0871
New Zealand
New Zealand Clinical Research
Auckland, New Zealand, 1010
Middlemore Clinical Trials
Papatoetoe, New Zealand, 2025
Poland
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
Gdansk, Poland, 80-462
ID Clinic
Myslowice, Poland, 41-400
Wojewodzki Szpital Zakazny w Warszawie
Warszawa, Poland, 01-201
Przychodnia EuroMediCare, Wroclaw Lowiecka
Wroclaw, Poland, 50-220
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
China Medical University Hospital
Taichung, Taiwan, 40447
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04667104    
Other Study ID Numbers: CR108928
2020-003956-34 ( EudraCT Number )
73763989PAHPB2006 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Virus Diseases
Herpesviridae Infections
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes
Tenofovir
Entecavir
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action