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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03577171 | A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV) | PHASE2 | COMPLETED | 25 | — | — | Jun 19, 2018 | Jun 21, 2019 | Jan 28, 2021 | 12 | United States, Canada +3 |
| NCT03576066 | A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection | PHASE2 | COMPLETED | 73 | — | — | Jun 11, 2018 | Jul 5, 2019 | Feb 17, 2021 | 21 | United States, Canada +1 |
| NCT03109730 | Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B | PHASE1 | COMPLETED | 38 | — | — | Jun 15, 2017 | Jun 12, 2018 | Jul 6, 2018 | 14 | Australia, Hong Kong +3 |
| NCT02908191 | A Study in Healthy Volunteers and Patients With Chronic Hepatitis B | PHASE1 | COMPLETED | 86 | — | — | Nov 1, 2016 | Jun 12, 2018 | Apr 4, 2019 | 2 | New Zealand |
Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
| Arm | Type | Description |
|---|---|---|
| ABI-H0731 + SOC ETV | EXPERIMENTAL | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. |
| Placebo + SOC ETV | EXPERIMENTAL | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. |
| ABI-H0731 + SOC NUC | EXPERIMENTAL | Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. |
| Placebo + SOC NUC | ACTIVE_COMPARATOR | Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. |
| Cohort B1 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B2 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B3 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B4 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B5 | EXPERIMENTAL | ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days |
| Cohort B6 | EXPERIMENTAL | ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days |
| ABI-H0731 or Matching Placebo | EXPERIMENTAL | ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days |
| ABI-H0731 or Placebo and ETV or TDF | EXPERIMENTAL | ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days |
| ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys | EXPERIMENTAL | ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days |
| Name | Type | Description |
|---|---|---|
| ABI-H0731 | DRUG | Participants will receive 300mg QD of ABI-H0731 tablets orally. |
| SOC ETV | DRUG | Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. |
| Placebo Oral Tablet | DRUG | Participants will receive matching QD placebo tablets orally. |
| SOC NUC | DRUG | Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert. |
| Placebo for ABI-H0731 | DRUG | Sugar pill manufactured to mimic the ABI-H0731 tablet |
| Entecavir | DRUG | An antiviral medication used in the treatment of hepatitis B virus infection |
| Tenofovir Disoproxil Fumarate | DRUG | An antiviral medication used in the treatment of hepatitis B virus infection |
| Pegasys | DRUG | Used to treat adults with chronic hepatitis B virus who show signs of liver damage |
| Nucleos(t)ide | DRUG | Used to treat adults with chronic hepatitis B virus |
Key Inclusion Criteria: * Male or female between ages 18 and 70 years * HBeAg-positive at screening * In good general health except for cHBV * HBV viral load ≥2×105 IU/mL * Hepatitis B surface antigen (HBsAg) \>1000 IU/mL at screening Key Exclusion Criteria: * Any prior treatment with lamivudine ...