Hepatitis B, ChronicPhase 2PENGUIN-2NCT05005507
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
A Phase 2 study testing JNJ-73763989, PegIFN-alpha-2a and Tenofovir disoproxil in people with Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 12 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- JNJ-73763989, PegIFN-alpha-2a and Tenofovir disoproxil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 3 Nov 2021to 29 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Spain4 sites
Hosp. Univ. Vall D Hebron
Barcelona, 8035
Hosp. Univ. Infanta Leonor
Madrid, 28032
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Hosp. Alvaro Cunqueiro
Vigo, 36213
Poland3 sites
PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
Gdansk, 80405
ID Clinic
Mysłowice, 41-400
EMC Instytut Medyczny SA
Wroclaw, 50-220
Canada2 sites
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z 2C7
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, V6Z 2K5
About this study
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
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).
Read the 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).
- Conditions
- Hepatitis B, Chronic
- Being tested
- JNJ-73763989, PegIFN-alpha-2a, Tenofovir disoproxil, TAF, ETV
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-73763989Drug
Also called JNJ-3989
JNJ-73763989 will be administered subcutaneously once every 4 weeks.
PegIFN-alpha-2aDrug
PegIFN-alpha-2a will be administered subcutaneously once weekly.
Tenofovir disoproxilDrug
Tenofovir disoproxil film-coated tablet will be administered orally once daily.
TAFDrug
TAF film-coated tablet will be administered orally once daily.
ETVDrug
ETV film-coated tablet will be administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: JNJ-73763989 + nucleos(t)ide analog (NA) + pegylated interferon alpha-2a (PegIFN-alpha-2a) | Experimental | 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. Receives: Drug: JNJ-73763989; Drug: PegIFN-alpha-2a; Drug: Tenofovir disoproxil; Drug: TAF; Drug: ETV |
| Arm 2: JNJ-73763989 + NA + PegIFN-alpha-2a | Experimental | 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. Receives: Drug: JNJ-73763989; Drug: PegIFN-alpha-2a; Drug: Tenofovir disoproxil; Drug: TAF; Drug: ETV |
| Arm 3: JNJ-73763989 + NA + PegIFN-alpha-2a | Experimental | 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. Receives: Drug: JNJ-73763989; Drug: PegIFN-alpha-2a; Drug: Tenofovir disoproxil; Drug: TAF; Drug: ETV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Reduction of at Least 2log10 International Units Per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline at Week 24 (End of Study Intervention [EOSI])
Percentage of participants with a reduction of at least 2log10 IU/mL in HBsAg levels from baseline at Week 24 (EOSI) were planned to be reported.
Measured: Week 24
Secondary outcomes (23)
Percentage of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Up to 1 month 26 days
Percentage of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measured: Up to 1 month 26 days
Percentage of Participants With Abnormalities in Clinical Laboratory Tests
Percentage of participants with abnormalities in clinical laboratory tests including hematology, blood coagulation, blood biochemistry, urinalysis, urine chemistry, renal biomarkers, were reported.
Measured: Up to 1 month 26 days
Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs)
Percentage of participants with abnormalities in 12-Lead ECGs were reported.
Measured: Up to 1 month 26 days
Percentage of Participants With Abnormalities in Vital Signs
Percentage of participants with abnormalities in vital signs were reported.
Measured: Up to 1 month 26 days
Percentage of Participants With Abnormalities in Ophthalmologic Examination
Percentage of participants with abnormalities in ophthalmologic examination were planned to be reported.
Measured: Weeks 8 and 20
Percentage of Participants With Abnormalities in Physical Examination
Percentage of participants with abnormalities in physical examination were planned to be reported.
Measured: Week 24
Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up Week 2 Visits
Percentage of participants meeting the protocol-defined NA treatment completion criteria based on the Week 24 (EOSI) or follow-up Week 2 visits was planned to be reported. NA treatment completion criteria were as follows: (a) participant had alanine transaminase (ALT) <3*upper limits of normal (ULN); (b) participant had Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) <20 international units per milliliter (IU/mL); (c) participant was Hepatitis B e antigen (HBeAg)-negative; (d) participant had Hepatitis B surface antigen (HBsAg<10 IU/mL.
Measured: Week 24 (EOSI) and follow-up Week 2
Percentage of Participants With HBsAg Seroclearance at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment
Percentage of participants with HBsAg seroclearance at follow-up Weeks 24 and 48 without re-starting NA treatment were planned to be reported. Seroclearance of HBsAg is defined as a (quantitative) HBsAg level <lower limit of quantitation (LLOQ). LLOQ is 0.05 International Units per milliliter (IU/mL).
Measured: Follow-up Weeks 24 and 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < (Less Than) LLOQ at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment
Percentage of participants with HBV DNA <LLOQ at follow-up Weeks 24 and 48 without re-starting NA treatment were planned to be reported. LLOQ is 0.05 IU/mL.
Measured: Follow-up Weeks 24 and 48
Percentage of Participants With Virologic Flares
Percentage of participants with virologic flares were reported. The start of a confirmed virologic flare is defined as the first date of two consecutive visits with HBV DNA >200 IU/mL. The end date of the same confirmed virologic flare is defined as the first date when HBV DNA value returns to less than or equal to (<=)200 IU/mL or the date of NA treatment restart, whichever comes first.
Measured: Up to 1 month 26 days
Percentage of Participants With Biochemical Flares
Percentage of participants with biochemical flares were reported. The start date of a confirmed off-treatment biochemical flare: the first date of two consecutive visits with ALT and/or AST>=3x ULN and >=3x off-treatment/on-treatment nadir (that is, lowest value observed during off-treatment period up to the time point of meeting the biochemical flare criteria) while the participant does not receive any of the study interventions. The end date of the same off-treatment/on-treatment biochemical flare: the first date when there is a 50% reduction from the peak ALT and/or AST level \& <3x ULN.
Measured: Up to 1 month 26 days
Percentage of Participants Requiring Nucleos(t)Ide Analog (NA) Re-treatment
Percentage of participants requiring NA re-treatment were planned to be reported.
Measured: Up to 72 weeks
Percentage of Participants With HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs
Percentage of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs were planned to be reported.
Measured: Up to 72 weeks
Percentage of Participants With HBsAg Seroconversion
Percentage of participants with HBsAg seroconversion were planned to be reported. Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance (quantitative HBsAg level <LLOQ) and appearance of anti-HBs antibodies. LLOQ is 0.05 IU/mL.
Measured: Up to 72 weeks
Change From Baseline in HBsAg Over Time
Change from baseline in HBsAg over time were planned to be reported.
Measured: Baseline up to Week 72
Time to Achieve HBsAg Seroclearance
Time to achieve HBsAg seroclearance were planned to be reported. Time to achieve HBsAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance (that is, the date of the first HBsAg seroclearance - the date of first study intervention intake + 1). Seroclearance of HBsAg is defined as a (quantitative) HBsAg level <LLOQ. LLOQ is 0.05 IU/mL.
Measured: Up to 72 weeks
Time to Achieve HBsAg Seroconversion
Time to achieve HBsAg seroconversion were planned to be reported. Time to achieve HBsAg seroconversion is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance and appearance of anti-HBs antibodies (that is, the date of the first HBsAg seroclearance and anti-HBs antibodies - the date of first study intervention intake + 1). Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance (quantitative HBsAg level <LLOQ) and appearance of anti-HBs antibodies. LLOQ is 0.05 IU/mL.
Measured: Up to 72 weeks
Time to Achieve HBV DNA <Lower Limit of Quantitation (LLOQ)
Time to achieve HBV DNA <LLOQ were planned to be reported. Time to achieve HBV DNA <LLOQ is defined as the number of days between HBV DNA >LLOQ for participants who re-treated with NA and the date of the first occurrence of HBV DNA < LLOQ after NA re-treatment (that is, the date of the HBV DNA < LLOQ after being re-treated with NA - the date of first occurrence of HBV DNA>LLOQ + 1). LLOQ is 0.05 IU/mL.
Measured: Up to 72 weeks
Percentage of Participants With Virologic Breakthrough
Percentage of participants with virologic breakthrough were planned to be reported. HBV virological breakthrough is defined as having a confirmed on-treatment HBV DNA increase by >1 log10 from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level below the LLOQ or a confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level below the LLOQ. LLOQ is 0.05 IU/mL.
Measured: Up to Week 24
Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976)
Serum concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976) were planned to be reported.
Measured: Up to 72 weeks
Serum Concentration of Nucleos(t)Ide Analog (NA) (Entecavir [ETV])
Serum concentration of NA (ETV) was planned to be reported.
Measured: Up to 72 weeks
Serum Concentration of PegIFN-alpha-2a
Serum concentration of PegIFN-alpha-2a was planned to be reported.
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start3 Nov 2021
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Why it stopped: A strategic decision was made to not further execute the study. This decision was not based on a safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005507
- Sponsor's protocol ID
- CR109070
- Other IDs
- 2021-002450-81, 73763989PAHPB2007
- Acronym
- PENGUIN-2
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2021
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05005507
- Acronym / sponsor ID
- PENGUIN-2 / CR109070
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A strategic decision was made to not further execute the study. This decision was not based on a safety concern.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: JNJ-73763989 + nucleos(t)ide analog (NA) + pegylated interferon alpha-2a (PegIFN-alpha-2a) | Experimental | Drug: JNJ-73763989, Drug: PegIFN-alpha-2a, Drug: Tenofovir disoproxil, Drug: TAF, Drug: ETVParticipants 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 2: JNJ-73763989 + NA + PegIFN-alpha-2a | Experimental | Drug: JNJ-73763989, Drug: PegIFN-alpha-2a, Drug: Tenofovir disoproxil, Drug: TAF, Drug: ETVParticipants 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 3: JNJ-73763989 + NA + PegIFN-alpha-2a | Experimental | Drug: JNJ-73763989, Drug: PegIFN-alpha-2a, Drug: Tenofovir disoproxil, Drug: TAF, Drug: ETVParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-73763989Also: JNJ-3989JNJ-73763989 will be administered subcutaneously once every 4 weeks. | Drug | 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 |
| PegIFN-alpha-2aPegIFN-alpha-2a will be administered subcutaneously once weekly. | Drug | 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 |
| Tenofovir disoproxilTenofovir disoproxil film-coated tablet will be administered orally once daily. | Drug | 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 |
| TAFTAF film-coated tablet will be administered orally once daily. | Drug | 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 |
| ETVETV film-coated tablet will be administered orally once daily. | Drug | 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 |
Primary outcome
Percentage of Participants With a Reduction of at Least 2log10 International Units Per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline at Week 24 (End of Study Intervention [EOSI])
Time frame: Week 24
Percentage of participants with a reduction of at least 2log10 IU/mL in HBsAg levels from baseline at Week 24 (EOSI) were planned to be reported.
23 secondary outcomes
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 1 month 26 days
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 1 month 26 days
Percentage of Participants With Abnormalities in Clinical Laboratory Tests
Time frame: Up to 1 month 26 days
Percentage of Participants With Abnormalities in 12-Lead Electrocardiograms (ECGs)
Time frame: Up to 1 month 26 days
Percentage of Participants With Abnormalities in Vital Signs
Time frame: Up to 1 month 26 days
Percentage of Participants With Abnormalities in Ophthalmologic Examination
Time frame: Weeks 8 and 20
Percentage of Participants With Abnormalities in Physical Examination
Time frame: Week 24
Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up Week 2 Visits
Time frame: Week 24 (EOSI) and follow-up Week 2
Percentage of Participants With HBsAg Seroclearance at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment
Time frame: Follow-up Weeks 24 and 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < (Less Than) LLOQ at Follow-up Weeks 24 and 48 Without Re-starting NA Treatment
Time frame: Follow-up Weeks 24 and 48
Percentage of Participants With Virologic Flares
Time frame: Up to 1 month 26 days
Percentage of Participants With Biochemical Flares
Time frame: Up to 1 month 26 days
Percentage of Participants Requiring Nucleos(t)Ide Analog (NA) Re-treatment
Time frame: Up to 72 weeks
Percentage of Participants With HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs
Time frame: Up to 72 weeks
Percentage of Participants With HBsAg Seroconversion
Time frame: Up to 72 weeks
Change From Baseline in HBsAg Over Time
Time frame: Baseline up to Week 72
Time to Achieve HBsAg Seroclearance
Time frame: Up to 72 weeks
Time to Achieve HBsAg Seroconversion
Time frame: Up to 72 weeks
Time to Achieve HBV DNA <Lower Limit of Quantitation (LLOQ)
Time frame: Up to 72 weeks
Percentage of Participants With Virologic Breakthrough
Time frame: Up to Week 24
Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976)
Time frame: Up to 72 weeks
Serum Concentration of Nucleos(t)Ide Analog (NA) (Entecavir [ETV])
Time frame: Up to 72 weeks
Serum Concentration of PegIFN-alpha-2a
Time frame: Up to 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-73763989, PegIFN-alpha-2a and Tenofovir disoproxil in people with Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Poland, Canada, United States, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Reduction of at Least 2log10 International Units Per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline at Week 24 (End of Study Intervention [EOSI]) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.