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New treatment option for Liver Fibrosis
Official title Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
ClinicalTrials.gov ID: NCT05905172
What this study is testing
What is Hydronidone capsules?
Hydronidone capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for liver fibrosis.
Also referred to as F351.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participate in the Phase III trial of this project (Protocol Number: KDN-F351- 202101 ，ClinicalTrials.gov ID: NCT05115942 ), complete the main...
- Before the trial, the subject understood the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial...
You likely can't join if
- One of any clinical endpoints occurred during the phase III trial (Note: for non cirrhotic patients, Clinical endpoints include progression to...
- Patients with malignant tumors other than hepatocellular carcinoma and with an expected survival period of less than 1 year;
- Any opinion of the investigator that may affect the subject to provide informed consent or follow the trial protocol, or participation in the trial...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Beijing, China
- Bengbu, China
- Changsha, China
- Chongqing, China
- Guizhou, China
- Hangzhou, China
- Henan, China
- Luzhou, China
- Nanchang, China
- Nanjing, China
- Ningbo, China
- Shanghai, China
- Shenzhen, China
- Xinxiang, China
- Yanbian, China
- Zhenjiang, China
- Zunyi, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Beijing, China; Bengbu, China; Changsha, China; Chongqing, China and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.