Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase IIIb Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B
About This Trial
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B". The main objective of this study is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Hydronidone capsules
After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.
The placebo capsules
After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 5 years.