Trial reportLiver international : official journal of the International Association for the Study of the Liver2026
Safety, Tolerability and Antiviral Activity of GST-HG131 in Chronic Hepatitis B: A Randomized, Double-Blind Phase IIa Study.
Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06263959 (A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B), which is not on this map. Cited by 1 paper.
What it found
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The trial behind it
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A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
Who cites it
1 citing paper in PubMed.
- Safety, Tolerability and Antiviral Activity of GST-HG131 in Chronic Hepatitis B: A Randomized, Double-Blind Phase IIa Study.Liver international : official journal of the International Association for the Study of the Liver · 2026Trial
Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
BACKGROUND AND
aimsChronic hepatitis B (CHB) remains a major global health burden. Current therapies rarely achieve a functional cure due to low rates of HBsAg clearance, the persistence of the viral replication template-covalently closed circular DNA (cccDNA)-and the need for lifelong treatment. GST-HG131 is a first-in-class, orally bioavailable small-molecule inhibitor of PAPD5/7, key host factors involved in HBV mRNA stabilization and HBsAg production. We evaluated the safety, tolerability and antiviral activity of GST-HG131 in patients with CHB receiving nucleos(t)ide analogue (NUC) therapy in a randomized, double-blind, placebo-controlled Phase IIa study.
methodsThis double-blind, randomized, placebo-controlled Phase IIa study evaluated the efficacy and safety of GST-HG131 in 45 CHB patients. Cohorts 1 and 2 (n = 10 each; 8 active, 2 placebo) received 30 mg or 60 mg BID for 28 days, respectively. Cohort 3 (n = 25; 20 active, five placebo) received 30 mg BID for 12 weeks. All participants were on nucleos(t)ide analog monotherapy for more than 6 months, with HBsAg between 100 and 1500 IU/mL, and serum ALT below 1× ULN.
resultsAt Day 28, HBsAg reductions were -0.65 log
conclusionGST-HG131, a first-in-class oral PAPD5/7 inhibitor, demonstrated favourable safety and significant HBsAg reduction in patients with CHB. The greatest antiviral activity was observed after 12 weeks of treatment, supporting further clinical development of GST-HG131 as a component of functional cure strategies for CHB.
trial registrationClinicalTrials.gov identifier: NCT06263959.
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