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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04676724 | Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB) | PHASE2 | COMPLETED | 108 | — | — | Jan 28, 2021 | Feb 17, 2023 | May 2, 2024 | 49 | United States, Canada +9 |
| NCT04544956 | A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B | PHASE2 | COMPLETED | 12 | — | — | Oct 6, 2020 | Nov 30, 2023 | Jul 15, 2025 | 4 | United States, Canada +2 |
| NCT04449029 | A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB) | PHASE2 | COMPLETED | 457 | — | — | Jul 27, 2020 | Mar 18, 2022 | May 16, 2023 | 121 | United States, Argentina +20 |
| NCT04971928 | Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment | PHASE1 | COMPLETED | 24 | — | — | Sep 7, 2021 | May 12, 2022 | Sep 27, 2022 | 2 | United States |
Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off.
Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off.
Percentage of participants achieving serum HBsAg level \<LLOQ were reported. Percentage values are rounded-off.
The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.
| Arm | Type | Description |
|---|---|---|
| GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks) | EXPERIMENTAL | Participants on stable NA therapy received 300 milligrams per week (mg/week) GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by Pegylated Interferon (PegIFN) 180 microgram per week (mcg/week) up to 24 weeks. |
| GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks) | EXPERIMENTAL | Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks. |
| GSK3228836 300 mg | EXPERIMENTAL | Participants on stable nucleos(t)ide therapy will receive GSK3228836 300 mg subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11). |
| Cohort 1: GSK3228836 300 mg + LD | EXPERIMENTAL | Eligible participants on stable nucleos(t)ide treatment will receive 300 milligrams (mg) GSK3228836 once weekly for 24 weeks along with loading dose (LD) of 300 mg GSK3228836 on Day 4 and Day 11. |
| Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo | EXPERIMENTAL | Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding. |
| Cohort 1: GSK3228836 300 mg + LD/ Placebo | EXPERIMENTAL | Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks. |
| Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD | EXPERIMENTAL | Eligible participants on stable nucleos(t)ide treatment will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11. |
| Cohort 2: GSK3228836 300 mg + LD | EXPERIMENTAL | Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 24 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11. |
| Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo | EXPERIMENTAL | Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding. |
| Cohort 2: GSK3228836 300 mg + LD/ Placebo | EXPERIMENTAL | Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks. |
| Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD | EXPERIMENTAL | Eligible participants not currently on nucleos(t)ide therapy will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11. |
| Participants with Moderate (CP-B) hepatic impairment | EXPERIMENTAL | - |
| Participants with Mild (CP-A) hepatic impairment | EXPERIMENTAL | - |
| Healthy participants | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK3228836 | DRUG | Participants will be administered GSK3228836. |
| PegIFN | DRUG | Participants will be administered PegIFN. |
| NA therapy | DRUG | Participants will continue to receive their NA therapy for the duration of the study. |
| Nucleos(t)ide therapy | DRUG | Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleos(t)ide therapy for the duration of the study. |
| Placebo | DRUG | Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly. |
Inclusion Criteria: * 18 to 75 years of age at the time of signing the informed consent. * Participants who are eligible to be treated with PegIFN. * Documented chronic HBV infection \>=6 months prior to screening and currently receiving stable NA therapy except telbivudine, defined as no changes t...