Trials / Completed
CompletedNCT02499562
A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
Randomed and Double-blinded Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Shanghai Genomics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
Detailed description
Primary observation indexes: Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment. Secondary observation indexes : 1. Negative conversion ratio of HBV DNA after treatment (HBV DNA\<1×103copies/mL) and falling range. 2. The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment. 3. The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment. 4. The improvement of ALT of liver function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydronidone | The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases. |
| DRUG | Placebo | |
| DRUG | Entecavir |
Timeline
- Start date
- 2015-06-25
- Primary completion
- 2020-11-20
- Completion
- 2020-11-20
- First posted
- 2015-07-16
- Last updated
- 2022-06-23
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02499562. Inclusion in this directory is not an endorsement.