Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03361956 | An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection | PHASE2 | COMPLETED | 232 | — | — | Feb 13, 2018 | Aug 13, 2020 | Nov 17, 2022 | 76 | United States, Belgium +17 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part A: Arm 1 (JNJ-56136379 or NA) (open label) | EXPERIMENTAL | Participants with hepatitis B virus (HBV) currently not being treated and receiving JNJ-56136379 tablet (at a lower dose) orally for 24 weeks, will stop further dosing with JNJ-56136379 and start treatment with nucleos(t)ide analog (NA) (entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\]), and enter the 24 week post treatment follow-up phase. |
| Part A: Arm 2 (Placebo+NA [ETV] or [TDF]) | PLACEBO_COMPARATOR | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 along with NA (ETV or TDF) tablet orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 4 (Placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Virologically suppressed participants will receive JNJ-56136379 along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 6 (JNJ-56136379 + NA [ETV or TDF]) (open label) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose, orally for 24 weeks. The eligible participants may enter the extension phase and will receive JNJ-56136379 along with NA (ETV or TDF) from Week 24 to Week 48. |
| Part B: Arm 7 (placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 9 (placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Virologically suppressed participants will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Name | Type | Description |
|---|---|---|
| JNJ-56136379 | DRUG | Participants will receive JNJ-56136379 tablet orally. |
| Placebo | DRUG | Participants will receive matching placebo tablet orally. |
| NA (ETV or TDF) | DRUG | Participants will receive NA (ETV or TDF) tablet orally as per approved label. |
Inclusion Criteria: * Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m\^2), extremes included * Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum h...