drugset / Trial / NCT02499562

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

NCT02499562

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

Drugs

EvaluationDrugModalityDoseRoute
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