A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Continent Pharmaceutical Co, Ltd.
About this trial
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. The medication will be administered orally half an hour before meals for a total of 28 days.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.
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 last dose of the investigational product, and agrees not to donate eggs for reproductive purposes during this period.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hydronidone capsules
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Beijing Continent Pharmaceutical Co, Ltd.
Lead sponsor
The First Hospital of Jilin University
Collaborator
Source ClinicalTrials.gov