drugset / Trial / NCT03576066

A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

Phase 2 Completed 73 enrolled Assembly Biosciences

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).

Timeline

Start: 2018-06-11
Primary completion: 2019-07-05
Completion: 2019-07-05

Outcome

Missed primary endpoint

paper In HBeAg-positive and -negative patients, there were no differences in the change from Baseline at Week 24 for HBsAg or HBeAg. PMID 35460726 ↗

registry analysis (other test); HBeAg-positive Participants: ABI-H0731 + SOC NUC vs HBeAg-positive Participants: Placebo + SOC NUC; p = 0.6855; Repeated measures analysis NCT03576066 ↗

registry analysis (other test); HBeAg-negative Participants: ABI-H0731 + SOC NUC vs HBeAg-negative Participants: Placebo + SOC NUC; p = 0.1750; Repeated measures analysis NCT03576066 ↗

registry analysis (other test); HBeAg-positive Participants: ABI-H0731 + SOC NUC vs HBeAg-positive Participants: Placebo + SOC NUC; p = 0.2916; Repeated measures analysis NCT03576066 ↗

Publications

Yuen MF, Agarwal K, Ma X, Nguyen TT, Schiff ER, Hann HL, Dieterich DT, Nahass RG, Park JS, Chan S, Han SB, Gane EJ, Bennett M, Alves K, Evanchik M, Yan R, Huang Q, Lopatin U, Colonno R, Ma J, Knox SJ, Stamm LM, Bonacini M, Jacobson IM, Ayoub WS, Weilert F, Ravendhran N, Ramji A, Kwo PY, Elkhashab M, Hassanein T, Bae HS, Lalezari JP, Fung SK, Sulkowski MS. Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection. J Hepatol. 2022 Sep;77(3):642-652. doi: 10.1016/j.jhep.2022.04.005. Epub 2022 Apr 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vebicorvir	Small molecule	300 mg	Oral
Background	Entecavir	Small molecule	—	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	—	Oral
Background	tenofovir alafenamide	Small molecule	—	Oral