Trial · NCT03361956
An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection
NCT03361956, Phase 2, Completed, Janssen Sciences Ireland UC; results first posted 2022-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection. Trials, record NCT03361956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03361956
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection
- NCT number
- NCT03361956
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 232 participants, actual
- Lead sponsor
- Janssen Sciences Ireland UC
- Conditions
- Hepatitis B
- Interventions
- JNJ-56136379, Placebo, NA (ETV or TDF)
- First posted
- 2017-12-05
- Last updated
- 2022-11-17
- Other registries' IDs
- eudract:2017-001110-29
- Results first posted
- 2022-11-17
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Baseline and Week 24 | Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline. |
| Primary | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | Baseline and Week 24 | Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) \<60 IU/mL. This outcome measure was planned to be analyzed for specified arms only. |
| Secondary | Number of Participants With Treatment- Emergent Adverse Events (AEs) | Up to Week 48 | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs were AEs with onset during the treatment phase or that worsened since baseline. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Up to Week 80 | 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 Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Up to Week 80 | Number of participants with clinically significant changes in vital signs, physical examinations, ECG, and clinical laboratory tests (including hematology, blood biochemistry, blood coagulation, and urinalysis) were reported. |
| Secondary | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Weeks 24, 48 and Follow-up Week 24 | Change from baseline in HBsAg levels in currently not treated population based on HBeAg status was reported. |
| Secondary | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Weeks 24, 48 and Follow-up Week 24 | Change from baseline in HBsAg levels in virologically suppressed population based on HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only. |
| Secondary | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | Percentage of participants with HBsAg levels \<1,000 or \<100 IU/mL in currently not treated population based on their HBeAg status were reported. |
| Secondary | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Weeks 24, 48 and Follow-up Week 24 | Percentage of participants with HBsAg levels \<1,000 or \<100 IU/mL in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only. |
| Secondary | Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | Percentage of participants with \>0.5 log10 IU/mL or \>1 log10 IU/mL reduction in HBsAg from baseline in currently not treated population based on their HBeAg status were reported. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Baseline and Week 24 | Intent-to-Treat Population (ITT) consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n'(number analyzed) represents number of participants evaluable for the specified categories. | log10 IU per milliliter (log10 IU/mL) | MEAN |
| PRIMARY | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | Baseline and Week 24 | ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories. | log10 IU/mL | MEAN |
| SECONDARY | Number of Participants With Treatment- Emergent Adverse Events (AEs) | Up to Week 48 | The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | Up to Week 80 | The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Up to Week 80 | The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Weeks 24, 48 and Follow-up Week 24 | ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories. | log10 IU/mL | MEAN |
| SECONDARY | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Weeks 24, 48 and Follow-up Week 24 | ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories. | log10 IU/mL | MEAN |
| SECONDARY | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Weeks 24, 48 and Follow-up Week 24 | ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories. | Percentage of participants | NUMBER |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group994
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | HBeAg Positive | -0.251 | Standard Deviation 0.3144 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part A: JNJ-56136379 75 mg (Open Label) | HBeAg Positive | -0.096 | Standard Deviation 0.3567 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part A: JNJ-56136379 75 mg + NA | HBeAg Positive | -0.142 | Standard Deviation 0.3443 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part B: JNJ-56136379 250 mg (Open Label) | HBeAg Positive | -0.203 | Standard Deviation 0.4721 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part B: JNJ-56136379 250 mg + NA | HBeAg Positive | -0.411 | Standard Deviation 0.4843 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | HBeAg Negative | 0.015 | Standard Deviation 0.0880 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part A: JNJ-56136379 75 mg (Open Label) | HBeAg Negative | 0.053 | Standard Deviation 0.2066 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part A: JNJ-56136379 75 mg + NA | HBeAg Negative | 0.041 | Standard Deviation 0.0939 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part B: JNJ-56136379 250 mg (Open Label) | HBeAg Negative | 0.064 | Standard Deviation 0.0913 | log10 IU per milliliter (log10 IU/mL) |
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Part B: JNJ-56136379 250 mg + NA | HBeAg Negative | 0.088 | Standard Deviation 0.1613 | log10 IU per milliliter (log10 IU/mL) |
1 to 10 of 994Source ClinicalTrials.gov
See all 994 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 43 | |
| Overall Study | STARTED | Part A: JNJ-56136379 75 mg (Open Label) | 28 | |
| Overall Study | STARTED | Part A: JNJ-56136379 75 mg + NA | 66 | |
| Overall Study | STARTED | Part B: JNJ-56136379 250 mg (Open-label) | 32 | |
| Overall Study | STARTED | Part B: JNJ-56136379 250 mg + NA | 63 | |
| Overall Study | Currently Not Treated | Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 22 | |
| Overall Study | Currently Not Treated | Part A: JNJ-56136379 75 mg (Open Label) | 28 | |
| Overall Study | Currently Not Treated | Part A: JNJ-56136379 75 mg + NA | 33 | |
| Overall Study | Currently Not Treated | Part B: JNJ-56136379 250 mg (Open-label) | 32 | |
| Overall Study | Currently Not Treated | Part B: JNJ-56136379 250 mg + NA | 33 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events2,580
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 | Initial Treatment Phase: Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 0 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | Initial Treatment Phase: Part A: JNJ-56136379 75 mg (Open Label) | 0 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Initial Treatment Phase: Part A: JNJ-56136379 75 mg + NA | 0 | 66 | |
| other | Anaemia | Blood and lymphatic system disorders | Initial Treatment Phase: Part B: JNJ-56136379 250 mg (Open-label) | 0 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Initial Treatment Phase: Part B: JNJ-56136379 250 mg + NA | 0 | 63 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Extension Phase: Parts A and B: Pooled Placebo + NA | 0 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Extension Phase: Part A: JNJ-56136379 75 mg (Open Label) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Extension Phase: Part A: JNJ-56136379 75 mg + NA | 0 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Extension Phase: Part B: JNJ-56136379 250 mg (Open-label) | 1 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Extension Phase: Part B: JNJ-56136379 250 mg + NA | 1 | 48 |
1 to 10 of 2,580Source ClinicalTrials.gov
See all 2,580 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initial Treatment Phase: Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 0 | 43 |
| Total, all-cause mortality | Initial Treatment Phase: Part A: JNJ-56136379 75 mg (Open Label) | 0 | 28 |
| Total, all-cause mortality | Initial Treatment Phase: Part A: JNJ-56136379 75 mg + NA | 0 | 66 |
| Total, all-cause mortality | Initial Treatment Phase: Part B: JNJ-56136379 250 mg (Open-label) | 0 | 32 |
| Total, all-cause mortality | Initial Treatment Phase: Part B: JNJ-56136379 250 mg + NA | 0 | 63 |
| Total, all-cause mortality | Treatment Extension Phase: Parts A and B: Pooled Placebo + NA | 0 | 33 |
| Total, all-cause mortality | Treatment Extension Phase: Part A: JNJ-56136379 75 mg (Open Label) | 0 | 3 |
| Total, all-cause mortality | Treatment Extension Phase: Part A: JNJ-56136379 75 mg + NA | 0 | 43 |
| Total, all-cause mortality | Treatment Extension Phase: Part B: JNJ-56136379 250 mg (Open-label) | 0 | 20 |
| Total, all-cause mortality | Treatment Extension Phase: Part B: JNJ-56136379 250 mg + NA | 0 | 48 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers3
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/NCT03361956
GET https://conductscience.org/api/trials/v1/NCT03361956/registered?page=2