Trial · NCT04667104
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
NCT04667104, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2024-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04667104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04667104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT04667104
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Hepatitis B, Chronic
- Interventions
- JNJ-73763989, Tenofovir disoproxil, Tenofovir alafenamide (TAF), Entecavir (ETV) monohydrate, PegIFN-alpha2a
- First posted
- 2020-12-14
- Last updated
- 2024-07-03
- Other registries' IDs
- eudract:2020-003956-34
- Results first posted
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | From Baseline (Day 1) to Week 24 | Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24. |
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 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) | Percentage of participants with TEAEs were reported. An adverse event (AE) was 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. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. |
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | 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) | 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. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. 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. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | 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) | Number of participants with clinically significant abnormalities in vital signs (pulse rate, and blood pressure \[systolic and diastolic\]) were reported. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | 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) | Number of participants with clinically significant abnormalities in laboratory findings (including hematology, blood biochemistry, and urinalysis) were reported. Only parameters in which any participant had abnormality are reported below. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability | 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 | Number of participants with clinically significant abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected \[QTc\]) were reported. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Number of participants with clinically significant abnormalities in physical examination were reported. |
| Secondary | Number of Participants With Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Number of participants with abnormalities in Ophthalmic examination were planned to be reported. |
| Secondary | Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI) | At Week 24 (EOSI) | Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI were reported. NA treatment completion criteria are defined based on laboratory results at Week 24 were; HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, that is, lower limit of quantification(LLOQ); alanine aminotransferase(ALT) \<3\*ULN. |
| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | 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) | Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were as followed:\< 100 IU/mL, \< 10 IU/mL, \< 1 IU/mL, \< LLOQ (0.11 IU/mL). |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | From Baseline (Day 1) to Week 24 | Full Analysis Set (FAS) included all participants who were enrolled and who received at least 1 dose of study intervention within this intervention-specific appendix (ISA). Data for this outcome measure was planned to be collected and analyzed for specified arm only. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 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) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | 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) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | 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) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability | 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) | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this endpoint and n(number analyzed) signifies number of participants analyzed at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability | 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 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was not planned to be collected and analyzed for Follow-Up Period as pre-specified in protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability | Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was planned to be collected and analyzed at TP 1 and TP 2 for participants with diabetes/hypertension only. Since no subject had diabetes/hypertension hence data for this OM was not collected and analyzed as pre-specified in protocol. | ||
| SECONDARY | Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI) | At Week 24 (EOSI) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was not planned to be collected and analyzed for Treatment Period 1 and Follow-Up period as pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs | 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) | FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | percentage of participants | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group211
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 64.6 | 90% Confidence Interval 51.73 | percentage of participants | |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 52.1 | percentage of participants | ||
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 87.5 | percentage of participants | ||
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 60.4 | percentage of participants | ||
| Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | percentage of participants | ||
| Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 2.1 | percentage of participants | ||
| Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 8.3 | percentage of participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 0 | Participants |
1 to 10 of 211Source ClinicalTrials.gov
See all 211 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| TP 1: From Week 1 to Week 12 | STARTED | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 48 | |
| TP 1: From Week 1 to Week 12 | STARTED | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 0 | |
| TP 1: From Week 1 to Week 12 | STARTED | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 0 | |
| TP 1: From Week 1 to Week 12 | COMPLETED | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 48 | |
| TP 1: From Week 1 to Week 12 | COMPLETED | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 0 | |
| TP 1: From Week 1 to Week 12 | COMPLETED | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 0 | |
| TP 1: From Week 1 to Week 12 | NOT COMPLETED | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | |
| TP 1: From Week 1 to Week 12 | NOT COMPLETED | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 0 | |
| TP 1: From Week 1 to Week 12 | NOT COMPLETED | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 0 | |
| TP 2: From Week 12 to Week 24 | STARTED | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | 48 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 3 | 48 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 0 | 48 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | 48 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 4 | 48 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 0 | 48 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | 48 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 4 | 48 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 1 | 48 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | 48 | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | 48 |
| Total, all-cause mortality | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 0 | 48 |
| Total, all-cause mortality | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 0 | 48 |
| Total, other adverse events | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 12 | 48 |
| Total, other adverse events | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 35 | 48 |
| Total, other adverse events | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 20 | 48 |
| Total, serious adverse events | TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA | 0 | 48 |
| Total, serious adverse events | TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA | 1 | 48 |
| Total, serious adverse events | Follow-Up (FU) Period-nucleos(t)Ide Analog (NA) | 4 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40919077 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA vs TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA: Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04667104
GET https://conductscience.org/api/trials/v1/NCT04667104/registered?page=2