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A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection (PENGUIN-2)

Primary Purpose

Hepatitis B, Chronic

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-73763989
PegIFN-alpha-2a
Tenofovir disoproxil
TAF
ETV
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
  • Participants must have a body mass index between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive
  • Participants with chronic hepatitis B who should: a) be chronic hepatitis B e antigen (HBeAg) -negative; b) be anti-HBe antibody-positive; c) be currently receiving nucleos(t)ide analog (NA) treatment for at least 2 years prior to screening; d) have serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than (<) 60 international unit/milliliter (IU/mL) on 2 sequential measurements at least 6 months apart; e) have alanine aminotransferase (ALT) values < 2.0x upper limit of normal (ULN) on 2 sequential measurements at least 6 months apart
  • Hepatitis B surface antigen (HBsAg) greater than (>) 5 IU/mL at screening
  • Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (kPa) within 6 months prior to screening

Exclusion Criteria:

  • History or signs of cirrhosis or portal hypertension
  • Evidence of hepatitis A, C, D, E virus infection, or human immunodeficiency virus (HIV) infection
  • Liver disease of non-HBV etiology
  • Clinically relevant alcohol or drug abuse within 12 months of screening
  • Participants who meet any of the additional exclusion criteria for pegylated interferon alpha-2a (PegIFN- α2a) as described in local prescribing information (example, refer to Pegasys SmPC or Pegasys USPI) per the investigator's discretion. Key exclusion criteria for PegIFN- α2a include: a) Participants with signs or symptoms compatible with autoimmune disorders. b) Participants with bone marrow suppression. c) Participants with hypoglycaemia, hyperglycaemia, and/or diabetes mellitus, who cannot be effectively controlled by medication. d) Participants with pre-existing ophthalmologic disorders. e) Participants with one or more of the following laboratory abnormalities: i) Absolute neutrophil count less than (<)1,500 cells/mm3 (<1,000 cells/mm³ for black or African American participants). ii) Serum creatinine >1.5x ULN. iii) Inadequately controlled thyroid function (thyroid stimulating hormone [TSH] and thyroxine [T4]). f) Participants with a history of a severe psychiatric disorder including severe depression, suicidal ideation and attempted suicide, or a current depression or other psychiatric disorder that is not adequately controlled on a stable medication regimen

Sites / Locations

  • I.D. Care, Inc.
  • Vancouver ID Research and Care Centre Society
  • GI Research Institute (G.I.R.I.)
  • Kagawa Prefectural Central Hospital
  • PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
  • ID Clinic
  • EMC Instytut Medyczny SA
  • Hosp. Univ. Vall D Hebron
  • Hosp. Univ. Infanta Leonor
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Alvaro Cunqueiro
  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1: JNJ-73763989 + nucleos(t)ide analog (NA) + pegylated interferon alpha-2a (PegIFN-alpha-2a)

Arm 2: JNJ-73763989 + NA + PegIFN-alpha-2a

Arm 3: JNJ-73763989 + NA + PegIFN-alpha-2a

Arm Description

Participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks for 24 weeks plus NA treatment (either entecavir [ETV], tenofovir disoproxil or tenofovir alafenamide [TAF] tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly for 24 weeks.

Participants will receive JNJ-73763989 SC injection once every 4 weeks for 24 weeks plus NA treatment (either ETV, tenofovir disoproxil, or TAF tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly from Week 12 till Week 24.

Participants will receive JNJ-73763989 SC injection once every 4 weeks for 24 weeks plus NA treatment (either ETV, tenofovir disoproxil or TAF tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly from baseline till Week 12.

Outcomes

Primary Outcome Measures

Percentage of Participants with a Reduction of at least 2log10 IU/ml in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline at Week 24 (EOSI)
Percentage of participants with a reduction of at least 2 log10 international units per milliliters (IU/mL) in HBsAg levels from baseline at Week 24 (end of study intervention [EOSI]) will be reported.

Secondary Outcome Measures

Percentage of Participants with Adverse Events (AEs)
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.
Percentage of Participants with Serious Adverse Events (SAEs)
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.
Percentage of Participants with Abnormalities in Clinical Laboratory Tests
Percentage of participants with abnormalities in clinical laboratory test (including hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, renal biomarkers) will be reported.
Percentage of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)
Percentage of participants with abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected [QTc]) will be reported.
Percentage of Participants with Abnormalities in Vital Signs
Percentage of participants with abnormalities in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], and pulse rate) will be reported.
Percentage of Participants with Abnormalities in Ophthalmologic Examination
Percentage of participants with abnormalities in ophthalmologic examination will be reported.
Percentage of Participants with Abnormalities in Physical Examination
Percentage of participants with abnormalities in physical examination will be reported.
Percentage of Participants Meeting the Protocol- defined NA Treatment Completion Criteria Based on the Week 24 EOSI or Follow-up (FU) Week 2 Results
Percentage of participants meeting the protocol-defined NA treatment completion criteria based on the Week 24 (EOSI) or FU Week 2 results will be reported.
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Weeks 24 and 48 without Re-starting Nucleos(t)ide Analog (NA) Treatment
Percentage of participants with HBsAg seroclearance at FU Weeks 24 and 48 (after completion of all study interventions at Week 24) without re-starting NA treatment will be reported.
Percentage of Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <lower limit of quantification (LLOQ) at FU Weeks 24 and 48 Without Re-starting NA Treatment
Percentage of participants with HBV DNA <LLOQ at FU Weeks 24 and 48 (after completion of all study interventions at Week 24) without re-starting NA treatment will be reported.
Percentage of Participants with Virologic Flares
Percentage of participants with virologic flares will be reported.
Percentage of Participants with Biochemical Flares
Percentage of participants with biochemical flares will be reported.
Percentage of Participants Requiring NA Re-treatment
Percentage of participants requiring NA re-treatment based on failure in NA treatment completion criteria will be reported.
Percentage of Participants with HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs Over Time
Percentage of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time will be reported.
Percentage of Participants with HBsAg Seroconversion
Percentage of participants with HBsAg seroconversion will be reported.
Change from Baseline Over Time in HBsAg
Change from baseline over time in HBsAg will be reported.
Time to Achieve HBsAg Seroclearance/ Seroconversion
Time to achieve HBsAg seroclearance/ seroconversion will be reported.
Time to Achieve HBV DNA <LLOQ
Time to achieve HBV DNA <LLOQ will be reported.
Percentage of Participants with Virologic Breakthrough
Percentage of participants with virologic breakthrough will be reported.
Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976)
Serum samples will be analyzed to determine concentrations of JNJ-73763989 (JNJ-73763924 and JNJ-73763976).
Serum Concentration of NA
Serum samples will be analyzed to determine concentrations of NA.
Serum Concentration of PegIFN-alpha-2a
Serum samples will be analyzed to determine concentrations of PegIFN-alpha-2a.

Full Information

First Posted
August 12, 2021
Last Updated
December 28, 2022
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05005507
Brief Title
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
Acronym
PENGUIN-2
Official Title
A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
A strategic decision was made to not further execute the study. This decision was not based on a safety concern.
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
December 29, 2021 (Actual)
Study Completion Date
December 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment).
Detailed Description
JNJ-73763989 (JNJ-3989) is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via a ribonucleic acid interference (RNAi) mechanism. Combination treatment with JNJ-73763989 and NA has the potential to specifically decrease HBV viral antigen levels and inhibit viral replication. Since HBsAg is immune suppressive, the direct reduction of HBsAg levels by JNJ-73763989 is anticipated to contribute to the restoration of the immune response that is impaired in chronic HBV infection. Pegylated interferon (PegIFN) is an approved drug for the treatment of chronic HBV infection and after a finite treatment duration of 48 weeks results in slightly increased HBsAg seroclearance rates. The primary hypothesis of this study is that at least one of the combination regimens of JNJ-73763989+NA+PegIFN-alpha-2a is more efficacious than NA treatment alone (standard of care), as measured by the primary efficacy endpoint. This study will be conducted in 3 periods: Screening Period (4 weeks), Treatment Period (24 weeks) and Follow-up (FU) Period (48 weeks), starting at Week 24. Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, ophthalmologic examinations and physical examinations. Total duration of individual participation will be up to 76 weeks (including screening period).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: JNJ-73763989 + nucleos(t)ide analog (NA) + pegylated interferon alpha-2a (PegIFN-alpha-2a)
Arm Type
Experimental
Arm Description
Participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks for 24 weeks plus NA treatment (either entecavir [ETV], tenofovir disoproxil or tenofovir alafenamide [TAF] tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly for 24 weeks.
Arm Title
Arm 2: JNJ-73763989 + NA + PegIFN-alpha-2a
Arm Type
Experimental
Arm Description
Participants will receive JNJ-73763989 SC injection once every 4 weeks for 24 weeks plus NA treatment (either ETV, tenofovir disoproxil, or TAF tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly from Week 12 till Week 24.
Arm Title
Arm 3: JNJ-73763989 + NA + PegIFN-alpha-2a
Arm Type
Experimental
Arm Description
Participants will receive JNJ-73763989 SC injection once every 4 weeks for 24 weeks plus NA treatment (either ETV, tenofovir disoproxil or TAF tablets orally) once daily for 24 weeks plus PegIFN-alpha-2a SC injection once weekly from baseline till Week 12.
Intervention Type
Drug
Intervention Name(s)
JNJ-73763989
Other Intervention Name(s)
JNJ-3989
Intervention Description
JNJ-73763989 will be administered subcutaneously once every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
PegIFN-alpha-2a
Intervention Description
PegIFN-alpha-2a will be administered subcutaneously once weekly.
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil
Intervention Description
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
TAF
Intervention Description
TAF film-coated tablet will be administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
ETV
Intervention Description
ETV film-coated tablet will be administered orally once daily.
Primary Outcome Measure Information:
Title
Percentage of Participants with a Reduction of at least 2log10 IU/ml in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline at Week 24 (EOSI)
Description
Percentage of participants with a reduction of at least 2 log10 international units per milliliters (IU/mL) in HBsAg levels from baseline at Week 24 (end of study intervention [EOSI]) will be reported.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to Week 72
Title
Percentage of Participants with Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 72
Title
Percentage of Participants with Abnormalities in Clinical Laboratory Tests
Description
Percentage of participants with abnormalities in clinical laboratory test (including hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, renal biomarkers) will be reported.
Time Frame
Up to Week 72
Title
Percentage of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)
Description
Percentage of participants with abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected [QTc]) will be reported.
Time Frame
Up to Week 28
Title
Percentage of Participants with Abnormalities in Vital Signs
Description
Percentage of participants with abnormalities in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], and pulse rate) will be reported.
Time Frame
Up to Week 72
Title
Percentage of Participants with Abnormalities in Ophthalmologic Examination
Description
Percentage of participants with abnormalities in ophthalmologic examination will be reported.
Time Frame
Week 8
Title
Percentage of Participants with Abnormalities in Physical Examination
Description
Percentage of participants with abnormalities in physical examination will be reported.
Time Frame
Week 24
Title
Percentage of Participants Meeting the Protocol- defined NA Treatment Completion Criteria Based on the Week 24 EOSI or Follow-up (FU) Week 2 Results
Description
Percentage of participants meeting the protocol-defined NA treatment completion criteria based on the Week 24 (EOSI) or FU Week 2 results will be reported.
Time Frame
Week 24 and FU Week 2
Title
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Weeks 24 and 48 without Re-starting Nucleos(t)ide Analog (NA) Treatment
Description
Percentage of participants with HBsAg seroclearance at FU Weeks 24 and 48 (after completion of all study interventions at Week 24) without re-starting NA treatment will be reported.
Time Frame
Follow-up Weeks 24 and 48
Title
Percentage of Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <lower limit of quantification (LLOQ) at FU Weeks 24 and 48 Without Re-starting NA Treatment
Description
Percentage of participants with HBV DNA <LLOQ at FU Weeks 24 and 48 (after completion of all study interventions at Week 24) without re-starting NA treatment will be reported.
Time Frame
Follow-up Weeks 24 and 48
Title
Percentage of Participants with Virologic Flares
Description
Percentage of participants with virologic flares will be reported.
Time Frame
Up to Week 72
Title
Percentage of Participants with Biochemical Flares
Description
Percentage of participants with biochemical flares will be reported.
Time Frame
Up to Week 72
Title
Percentage of Participants Requiring NA Re-treatment
Description
Percentage of participants requiring NA re-treatment based on failure in NA treatment completion criteria will be reported.
Time Frame
Up to Week 72
Title
Percentage of Participants with HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs Over Time
Description
Percentage of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time will be reported.
Time Frame
Up to Week 72
Title
Percentage of Participants with HBsAg Seroconversion
Description
Percentage of participants with HBsAg seroconversion will be reported.
Time Frame
Up to Week 72
Title
Change from Baseline Over Time in HBsAg
Description
Change from baseline over time in HBsAg will be reported.
Time Frame
Baseline up to Week 72
Title
Time to Achieve HBsAg Seroclearance/ Seroconversion
Description
Time to achieve HBsAg seroclearance/ seroconversion will be reported.
Time Frame
Up to Week 72
Title
Time to Achieve HBV DNA <LLOQ
Description
Time to achieve HBV DNA <LLOQ will be reported.
Time Frame
Up to Week 72
Title
Percentage of Participants with Virologic Breakthrough
Description
Percentage of participants with virologic breakthrough will be reported.
Time Frame
Up to Week 24
Title
Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976)
Description
Serum samples will be analyzed to determine concentrations of JNJ-73763989 (JNJ-73763924 and JNJ-73763976).
Time Frame
Days 1, 29, 85, 113, 169
Title
Serum Concentration of NA
Description
Serum samples will be analyzed to determine concentrations of NA.
Time Frame
Days 1, 29, 85, 113, 169
Title
Serum Concentration of PegIFN-alpha-2a
Description
Serum samples will be analyzed to determine concentrations of PegIFN-alpha-2a.
Time Frame
Days 1, 29, 85, 113, 169

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening Participants must have a body mass index between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive Participants with chronic hepatitis B who should: a) be chronic hepatitis B e antigen (HBeAg) -negative; b) be anti-HBe antibody-positive; c) be currently receiving nucleos(t)ide analog (NA) treatment for at least 2 years prior to screening; d) have serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than (<) 60 international unit/milliliter (IU/mL) on 2 sequential measurements at least 6 months apart; e) have alanine aminotransferase (ALT) values < 2.0x upper limit of normal (ULN) on 2 sequential measurements at least 6 months apart Hepatitis B surface antigen (HBsAg) greater than (>) 5 IU/mL at screening Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (kPa) within 6 months prior to screening Exclusion Criteria: History or signs of cirrhosis or portal hypertension Evidence of hepatitis A, C, D, E virus infection, or human immunodeficiency virus (HIV) infection Liver disease of non-HBV etiology Clinically relevant alcohol or drug abuse within 12 months of screening Participants who meet any of the additional exclusion criteria for pegylated interferon alpha-2a (PegIFN- α2a) as described in local prescribing information (example, refer to Pegasys SmPC or Pegasys USPI) per the investigator's discretion. Key exclusion criteria for PegIFN- α2a include: a) Participants with signs or symptoms compatible with autoimmune disorders. b) Participants with bone marrow suppression. c) Participants with hypoglycaemia, hyperglycaemia, and/or diabetes mellitus, who cannot be effectively controlled by medication. d) Participants with pre-existing ophthalmologic disorders. e) Participants with one or more of the following laboratory abnormalities: i) Absolute neutrophil count less than (<)1,500 cells/mm3 (<1,000 cells/mm³ for black or African American participants). ii) Serum creatinine >1.5x ULN. iii) Inadequately controlled thyroid function (thyroid stimulating hormone [TSH] and thyroxine [T4]). f) Participants with a history of a severe psychiatric disorder including severe depression, suicidal ideation and attempted suicide, or a current depression or other psychiatric disorder that is not adequately controlled on a stable medication regimen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
I.D. Care, Inc.
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Vancouver ID Research and Care Centre Society
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
GI Research Institute (G.I.R.I.)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Kagawa Prefectural Central Hospital
City
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
City
Gdansk
ZIP/Postal Code
80405
Country
Poland
Facility Name
ID Clinic
City
Mysłowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
EMC Instytut Medyczny SA
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28032
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36213
Country
Spain
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection

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