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
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Participate in the Phase III trial of this project (Protocol Number: KDN-F351- 202101 ，ClinicalTrials.gov ID: NCT05115942 ), complete the main treatment course and the last visit;
• Before the trial, the subject understood the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, volunteered to participate in the clinical trial, was able to communicate well with the investigator, comply with the requirements of the whole study, and signed a written informed consent.
Locations
Other Locations
China
Beijing Ditan Hospital Capital Medical University
RECRUITING
Beijing
Beijing youan hospital, the capital of the capital
RECRUITING
Beijing
Tsinghua Changgeng Hospital, Beijing
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical University
RECRUITING
Bengbu
The Second Xiangya Hospital, Central South University
RECRUITING
Changsha
Xiangya Hospital, Central South University
RECRUITING
Changsha
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Three Gorges Hospital affiliated to Chongqing University