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Tests treatment safety and results for Chronic Hepatitis B With Hepatic Fibrosis
Official title A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
ClinicalTrials.gov ID: NCT07364448
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 an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis . Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.
- Patients assessed by the investigator as having chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated...
- people who agree to use effective contraception measures as specified below during their participation in the trial: Male people must consistently...
- Be a woman of non-childbearing potential (WONCBP), as defined in Appendix 1;
- Be a woman of childbearing potential (WOCBP) who consistently uses highly effective contraception methods as described in Appendix 1 from the time of...
You likely can't join if
- At screening, total bilirubin (TBIL) \> 3 × upper limit of normal (ULN), or direct bilirubin (DBIL) \> 2 × ULN, or alanine aminotransferase (ALT) \>...
- At screening, alpha-fetoprotein (AFP) \> 20 μg/L.
- At screening, platelet count (PLT) ≤ 75 × 10⁹/L, or international normalized ratio (INR) \> 1.5.
- History of or current clinical diagnosis of decompensated cirrhosis at screening, or imaging showing significant space-occupying lesions in the liver...
- Diagnosis of any other malignancy within the past 5 years prior to screening, except for radically resected and non-recurrent skin basal cell...
- Use of interferon within 3 months prior to screening.
See the full eligibility criteria
- Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.
- Patients assessed by the investigator as having chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated cirrhosis) based on histology, imaging, or laboratory markers...
- people who agree to use effective contraception measures as specified below during their participation in the trial: Male people must consistently employ highly effective contraception methods as described in Appendix 1...
- Be a woman of non-childbearing potential (WONCBP), as defined in Appendix 1;
- Be a woman of childbearing potential (WOCBP) who consistently uses highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the...
- The patient voluntarily agrees to participate in this trial, demonstrates good compliance, and has the capacity to understand and sign the informed consent form prior to the study.
- At screening, total bilirubin (TBIL) \> 3 × upper limit of normal (ULN), or direct bilirubin (DBIL) \> 2 × ULN, or alanine aminotransferase (ALT) \> 3 × ULN.
- At screening, alpha-fetoprotein (AFP) \> 20 μg/L.
- At screening, platelet count (PLT) ≤ 75 × 10⁹/L, or international normalized ratio (INR) \> 1.5.
- History of or current clinical diagnosis of decompensated cirrhosis at screening, or imaging showing significant space-occupying lesions in the liver (intrahepatic nodules \> 10 mm), or findings suggestive of malignancy.
- Diagnosis of any other malignancy within the past 5 years prior to screening, except for radically resected and non-recurrent skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer...
- Use of interferon within 3 months prior to screening.
- Concurrent severe diseases of the cardiovascular, pulmonary, renal, endocrine, neurological, digestive, or hematopoietic systems, or psychiatric disorders.
- Planned participation in other treatment clinical trials during the study period.
- Participation in any other clinical trials within 3 months prior to screening.
- Pregnant and/or lactating women.
- Other conditions deemed unsuitable for inclusion by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Jilin City, Changchun, 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 Jilin City, Changchun, 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.