Trial · NCT04585789
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
NCT04585789, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2024-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection. Trials, record NCT04585789. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04585789
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
- NCT number
- NCT04585789
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Hepatitis B
- Interventions
- JNJ-73763989, JNJ-56136379, Entecavir (ETV), Tenofovir disoproxil, Tenofovir alafenamide (TAF), PegIFN-alpha-2a (Optional)
- First posted
- 2020-10-14
- Last updated
- 2025-05-21
- Other registries' IDs
- eudract:2019-004475-39
- Results first posted
- 2024-03-05
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40 | Baseline, Week 40 | Absolute change from baseline to on-treatment liver biopsy timepoint (Week 40) in terms of the percentage of HBsAg-positive hepatocytes (at Week 40) were reported. |
| Primary | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12 | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | Liver concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 - Molecules of JNJ-73763989 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 12 were reported. |
| Primary | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40 | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | Liver concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 40 were reported. |
| Primary | Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12 | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | Plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 12 were reported. |
| Primary | Panel 3: Plasma Concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) at Week 40 | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | Plasma concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 40 were reported. |
| Primary | Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12 | Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 12 were reported. |
| Primary | Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40 | Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 40 were reported. |
| Secondary | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 2 at Follow-up Week 48 | Follow-up Week 48 | Percentage of participants with sustained (reduction) serum HBsAg response per Definition 2 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 2 was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow up visit: Among the most recent three visits, the difference between log HBsAg at 2 of 3 last visit and 1 of 3 last visit is \<0.2, and the difference between log HBsAg at 3 of 3 last visit and 1 of 3 last visit is \<0.2. |
| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroclearance | Follow-up Week 48 | Percentage of Participants who achieved HBsAg Seroclearance were reported. HBsAg seroclearance was defined as quantitative HBsAg \<LLOQ (\<0.05 IU/mL). |
| Secondary | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroclearance | Follow-up Week 48 | Percentage of Participants who achieved HBeAg Seroclearance were reported. HBeAg seroclearance was defined as (quantitative\] HBeAg \<LLOQ (\<0.11 IU/mL); with HBeAg positive status at baseline and became HBeAg negative post-baseline. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40 | Baseline, Week 40 | Intent-to-treat (ITT) population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panels 1 and 2 alone. | percentage of HBsAg hepatocytes | MEAN |
| PRIMARY | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12 | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | nanograms per gram (ng/g) | MEAN |
| PRIMARY | Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40 | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | ng/g | MEAN |
| PRIMARY | Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12 | At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | nanograms per milliliters (ng/mL) | MEAN |
| PRIMARY | Panel 3: Plasma Concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) at Week 40 | At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure (OM) was planned to be collected and analyzed for Panel 3 alone. | ng/mL | MEAN |
| PRIMARY | Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12 | Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | ratio | MEAN |
| PRIMARY | Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40 | Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989) | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone. | ratio | MEAN |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 2 at Follow-up Week 48 | Follow-up Week 48 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this OM. | Percentage of participants | NUMBER |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroclearance | Follow-up Week 48 | ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroclearance | Follow-up Week 48 | ITT population: participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. N(Number of participants analyzed) = number of participants evaluable for this outcome measure. Data was not collected for Panel 2 participants as they were HBeAg negative at enrollment and thus did not fulfill planned analysis criteria (HBeAg positive status). | percentage of participants | NUMBER |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group239
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40 | Panel 1 | -78.46 | 80% Confidence Interval -94.078 to -42.936 | percentage of HBsAg hepatocytes | |
| Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40 | Panel 2 | -5.68 | 80% Confidence Interval -15.846 to -0.885 | percentage of HBsAg hepatocytes | |
| Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12 | Panel 3 | JNJ-73763976 | 3550.00 | Standard Deviation 1674.714 | nanograms per gram (ng/g) |
| Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12 | Panel 3 | JNJ-73763924 | 87300.00 | Standard Deviation 31712.668 | nanograms per gram (ng/g) |
| Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12 | Panel 3 | M65 | 66175.00 | Standard Deviation 26000.817 | nanograms per gram (ng/g) |
| Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40 | Panel 3 | JNJ-73763976 | 5883.33 | Standard Deviation 2147.145 | ng/g |
| Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40 | Panel 3 | JNJ-73763924 | 208666.67 | Standard Deviation 66860.551 | ng/g |
| Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40 | Panel 3 | M65 | 133800.00 | Standard Deviation 50615.413 | ng/g |
| Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12 | Panel 3 | JNJ-73763976 | 254.70 | Standard Deviation 123.841 | nanograms per milliliters (ng/mL) |
| Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12 | Panel 3 | JNJ-73763924 | 36.18 | Standard Deviation 22.667 | nanograms per milliliters (ng/mL) |
1 to 10 of 239Source ClinicalTrials.gov
See all 239 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| OL Phase: Week 1 to Week 48 | STARTED | Panel 1 | 10 | |
| OL Phase: Week 1 to Week 48 | STARTED | Panel 2 | 10 | |
| OL Phase: Week 1 to Week 48 | STARTED | Panel 3 | 4 | |
| OL Phase: Week 1 to Week 48 | COMPLETED | Panel 1 | 10 | |
| OL Phase: Week 1 to Week 48 | COMPLETED | Panel 2 | 10 | |
| OL Phase: Week 1 to Week 48 | COMPLETED | Panel 3 | 4 | |
| OL Phase: Week 1 to Week 48 | NOT COMPLETED | Panel 1 | 0 | |
| OL Phase: Week 1 to Week 48 | NOT COMPLETED | Panel 2 | 0 | |
| OL Phase: Week 1 to Week 48 | NOT COMPLETED | Panel 3 | 0 | |
| FU Phase: Week 48 to Week 96 | STARTED | Panel 1 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events420
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 | Anaemia | Blood and lymphatic system disorders | OL Phase: Panel 1 | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | OL Phase: Panel 2 | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | OL Phase: Panel 3 | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | FU Phase: Panel 1 | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | FU Phase: Panel 2 | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | FU Phase: Panel 3 | 0 | 4 | |
| other | Neutropenia | Blood and lymphatic system disorders | OL Phase: Panel 1 | 0 | 10 | |
| other | Neutropenia | Blood and lymphatic system disorders | OL Phase: Panel 2 | 1 | 10 | |
| other | Neutropenia | Blood and lymphatic system disorders | OL Phase: Panel 3 | 1 | 4 | |
| other | Neutropenia | Blood and lymphatic system disorders | FU Phase: Panel 1 | 0 | 10 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OL Phase: Panel 1 | 0 | 10 |
| Total, all-cause mortality | OL Phase: Panel 2 | 0 | 10 |
| Total, all-cause mortality | OL Phase: Panel 3 | 0 | 4 |
| Total, all-cause mortality | FU Phase: Panel 1 | 0 | 10 |
| Total, all-cause mortality | FU Phase: Panel 2 | 0 | 10 |
| Total, all-cause mortality | FU Phase: Panel 3 | 0 | 4 |
| Total, other adverse events | OL Phase: Panel 1 | 9 | 10 |
| Total, other adverse events | OL Phase: Panel 2 | 10 | 10 |
| Total, other adverse events | OL Phase: Panel 3 | 3 | 4 |
| Total, other adverse events | FU Phase: Panel 1 | 5 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT04585789
GET https://conductscience.org/api/trials/v1/NCT04585789/registered?page=2