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Tests treatment safety and results for Chronic Hepatitis B With Hepatic Fibrosis
Official title A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
ClinicalTrials.gov ID: NCT07343778
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 chronic hepatitis b with hepatic fibrosis.
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 is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Eligible participants will be sequentially enrolled to receive hydronidone capsules 120 mg three times daily (TID) for 28 consecutive days.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
- Aged ≥18 years, regardless of gender.
- Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either: A prior percutaneous liver biopsy (results within 1 year prior to...
- Alanine aminotransferase (ALT) \< 8 × upper limit of normal (ULN).
- Female participants of childbearing potential must have a negative serum pregnancy test. Furthermore, the participant or their partner must agree to...
You likely can't join if
- History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders...
- Total bilirubin (TBIL) \> 3 × upper limit of normal (ULN), or ALT \> 3 × ULN but \ 2 × ULN.
- Alpha-Fetoprotein (AFP) \> 100 μg/L, even in the absence of clinical indications of hepatocellular carcinoma.
- Platelet count (PLT) ≤ 50 × 10⁹/L; Prothrombin activity (PTA) \ 1.5.
- Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any...
- Positive test for Human Immunodeficiency Virus antibody (HIV-Ab).
See the full eligibility criteria
- Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
- Aged ≥18 years, regardless of gender.
- Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either: A prior percutaneous liver biopsy (results within 1 year prior to enrollment are acceptable); or Imaging findings (Fibroscan, Fibrotouch, or...
- Alanine aminotransferase (ALT) \< 8 × upper limit of normal (ULN).
- Female participants of childbearing potential must have a negative serum pregnancy test. Furthermore, the participant or their partner must agree to employ highly effective contraceptive methods from the start of the...
- History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders affecting drug absorption at the time of screening.
- Total bilirubin (TBIL) \> 3 × upper limit of normal (ULN), or ALT \> 3 × ULN but \ 2 × ULN.
- Alpha-Fetoprotein (AFP) \> 100 μg/L, even in the absence of clinical indications of hepatocellular carcinoma.
- Platelet count (PLT) ≤ 50 × 10⁹/L; Prothrombin activity (PTA) \ 1.5.
- Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any infectious event requiring systemic anti-infective therapy.
- Positive test for Human Immunodeficiency Virus antibody (HIV-Ab).
- History of definite malignant tumors, or clinically significant dysfunction of major organs including heart, lungs, or kidneys, as well as clinically significant severe hepatic dysfunction unrelated to the underlying...
- Pregnant or lactating women.
- Participation in any other clinical trial and receipt of investigational drugs within 3 months prior to screening.
- Any other condition deemed by the investigator as unsuitable for enrollment or likely to prevent completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, China. 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.