drugset / Trial / NCT07364448
A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
Phase 2
Recruiting
200 enrolled
Beijing Continent Pharmaceutical Co, Ltd.
The First Hospital of Jilin University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis . Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.
Timeline
- Start
- 2026-03-12
- Primary completion
- 2026-07-30
- Completion
- 2026-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydronidone | Small molecule | 90 mg | Oral |