A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

Phase 2 Completed 168 enrolled Shanghai Genomics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.

Timeline

Start: 2015-06-25
Primary completion: 2020-11-20
Completion: 2020-11-20

Outcome

Met primary endpoint

paper The fibrosis improvement endpoint was achieved by 11 patients (25.6%) in the placebo group and 17 patients (40.5%) in the 180-mg group (P = .12), 23 patients (54.8%) in the 270-mg group (P = .006) PMID 35842120 ↗

paper The improvement rate was 58 of 125 (46.4%) in the combined hydronidone group (P = .014). PMID 35842120 ↗

release “羟尼酮联合恩替卡韦治疗慢性乙型肝炎患者肝纤维化的临床Ⅱ期试验获得令人鼓舞的良好结果，达到了主要研究终点指标” bjcontinent.com ↗

Publications

Cai X, Liu X, Xie W, Ma A, Tan Y, Shang J, Zhang J, Chen C, Yu Y, Qu Y, Zhang L, Luo Y, Yin P, Cheng J, Lu L. Hydronidone for the Treatment of Liver Fibrosis Related to Chronic Hepatitis B: A Phase 2 Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1893-1901.e7. doi: 10.1016/j.cgh.2022.05.056. Epub 2022 Jul 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydronidone	Small molecule	180 mg	Oral
Subject	Hydronidone	Small molecule	270 mg	Oral
Subject	Hydronidone	Small molecule	360 mg	Oral
Background	Entecavir	Small molecule	0.5 mg	Oral