Trial · NCT03982186
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
NCT03982186, Phase 2, Completed, Janssen Sciences Ireland UC; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection. Trials, record NCT03982186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03982186
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
- NCT number
- NCT03982186
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 471 participants, actual
- Lead sponsor
- Janssen Sciences Ireland UC
- Conditions
- Hepatitis B, Chronic
- Interventions
- JNJ-73763989, Placebo for JNJ-73763989, JNJ-56136379, Placebo for JNJ-56136379, Nucleos(t)ide Analog (NA)
- First posted
- 2019-06-11
- Last updated
- 2025-02-04
- Other registries' IDs
- eudract:2019-000622-22
- Results first posted
- 2024-07-10
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Week 48 | Percentage of participants meeting the NA treatment completion criteria at Week 48 were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (\<) 3\*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) \< lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) \<10 international units per milliliter (IU/mL). Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data. |
| Secondary | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to Week 48 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Secondary | Follow-up Phase 1: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Secondary | Follow-up Phase 2: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Secondary | Follow-up Phase 3: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Secondary | Extended Follow-up Phase: Percentage of Participants With TEAEs | Extended Follow up Week 1 to extended follow up Week 48 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Secondary | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | Baseline up to Week 48 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Secondary | Follow-up Phase 1: Percentage of Participants With SAEs | From Week 48 up to Week 96 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Secondary | Follow-up Phase 2: Percentage of Participants With SAEs | From Week 48 up to Week 96 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Secondary | Follow-up Phase 3: Percentage of Participants With SAEs | From Week 48 up to Week 96 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Week 48 | Modified Intent-to-Treat (mITT) set was defined as all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the COVID-19 pandemic defined as those participants who, because of COVID-19 or similar pandemic-related reasons, withdrew prematurely from the study prior to Week 44, or had no efficacy assessment for the primary outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to Week 48 | Safety analysis set included all participants who received at least one dose of any of the study treatments. | Percentage of participants | NUMBER |
| SECONDARY | Follow-up Phase 1: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | Safety analysis set included all participants who received at least one dose of any of the study treatments. | Percentage of participants | NUMBER |
| SECONDARY | Follow-up Phase 2: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase. | Percentage of participants | NUMBER |
| SECONDARY | Follow-up Phase 3: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase. | Percentage of participants | NUMBER |
| SECONDARY | Extended Follow-up Phase: Percentage of Participants With TEAEs | Extended Follow up Week 1 to extended follow up Week 48 | Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the follow up phase entered the extended follow up phase. | Percentage of participants | NUMBER |
| SECONDARY | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | Baseline up to Week 48 | Safety analysis set included all participants who received at least one dose of any of the study treatments. | Percentage of participants | NUMBER |
| SECONDARY | Follow-up Phase 1: Percentage of Participants With SAEs | From Week 48 up to Week 96 | Safety analysis set included all participants who received at least one dose of any of the study treatments. | Percentage of participants | NUMBER |
| SECONDARY | Follow-up Phase 2: Percentage of Participants With SAEs | From Week 48 up to Week 96 | Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase. | Percentage of participants | NUMBER |
| SECONDARY | Follow-up Phase 3: Percentage of Participants With SAEs | From Week 48 up to Week 96 | Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase. | Percentage of participants | NUMBER |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group1,355
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | 9.4 | 90% Confidence Interval 4.36 | Percentage of participants | |
| Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Arm 2: JNJ-73763989 200 mg + Placebo + NA | 19.1 | 90% Confidence Interval 12.76 | Percentage of participants | |
| Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Arm 3: JNJ-73763989 100 mg + Placebo + NA | 16.3 | 90% Confidence Interval 10.33 | Percentage of participants | |
| Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Arm 4: JNJ-73763989 40 mg + Placebo + NA | 5.5 | 90% Confidence Interval 2.19 | Percentage of participants | |
| Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Arm 5: Placebo + JNJ-56136379 250 mg + NA | 0.0 | 90% Confidence Interval 0.00 | Percentage of participants | |
| Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Arm 6: Placebo + Placebo + NA | 2.2 | 90% Confidence Interval 0.11 | Percentage of participants | |
| Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | 71.6 | Percentage of participants | ||
| Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA | 64.6 | Percentage of participants | ||
| Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 3: DB Phase: JNJ-73763989 100 mg + Placebo + NA | 71.0 | Percentage of participants | ||
| Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 4: DB Phase: JNJ-73763989 40 mg + Placebo + NA | 74.2 | Percentage of participants |
1 to 10 of 1,355Source ClinicalTrials.gov
See all 1,355 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | 95 | |
| Overall Study | STARTED | Arm 2: JNJ-73763989 200 mg + Placebo + NA | 96 | |
| Overall Study | STARTED | Arm 3: JNJ-73763989 100 mg + Placebo + NA | 93 | |
| Overall Study | STARTED | Arm 4: JNJ-73763989 40 mg + Placebo + NA | 94 | |
| Overall Study | STARTED | Arm 5: Placebo + JNJ-56136379 250 mg + NA | 48 | |
| Overall Study | STARTED | Arm 6: Placebo + Placebo + NA | 45 | |
| Overall Study | Double Blind Phase | Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | 95 | |
| Overall Study | Double Blind Phase | Arm 2: JNJ-73763989 200 mg + Placebo + NA | 96 | |
| Overall Study | Double Blind Phase | Arm 3: JNJ-73763989 100 mg + Placebo + NA | 93 | |
| Overall Study | Double Blind Phase | Arm 4: JNJ-73763989 40 mg + Placebo + NA | 93 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events8,010
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 | Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | 2 | 95 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA | 2 | 96 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 3: DB Phase: JNJ-73763989 (100 mg) + Placebo + NA | 3 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 4: DB Phase: JNJ-73763989 (40 mg) + Placebo + NA | 3 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA | 1 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 6: DB Phase: Placebo + Placebo + NA | 3 | 45 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA | 1 | 81 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA | 1 | 70 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA | 1 | 71 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA | 0 | 85 |
1 to 10 of 8,010Source ClinicalTrials.gov
See all 8,010 adverse eventsAdverse event totals90
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | 0 | 95 |
| Total, all-cause mortality | Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA | 0 | 96 |
| Total, all-cause mortality | Arm 3: DB Phase: JNJ-73763989 (100 mg) + Placebo + NA | 0 | 93 |
| Total, all-cause mortality | Arm 4: DB Phase: JNJ-73763989 (40 mg) + Placebo + NA | 0 | 93 |
| Total, all-cause mortality | Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA | 0 | 48 |
| Total, all-cause mortality | Arm 6: DB Phase: Placebo + Placebo + NA | 0 | 45 |
| Total, all-cause mortality | Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA | 0 | 81 |
| Total, all-cause mortality | Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA | 0 | 70 |
| Total, all-cause mortality | Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA | 0 | 71 |
| Total, all-cause mortality | Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA | 0 | 85 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT03982186
GET https://conductscience.org/api/trials/v1/NCT03982186/registered?page=2