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L'essai clinique NCT07412236 pour Fibrose du foie, Liver Fibrosis in Chronic Hepatitis B est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B. Phase III 1 208 Randomisé Double aveugle Contrôlé par placebo

Pas encore en recrutement
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L'essai clinique NCT07412236 est conçu pour étudier le traitement de Fibrose du foie, Liver Fibrosis in Chronic Hepatitis B. Il s'agit d'une étude interventionnel en Phase III. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 30 janvier 2026, avec un objectif de 1 208 participants. Dirigée par Gyre Therapeutics, l'étude devrait être terminée d'ici le 30 décembre 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 février 2026.
Résumé succinct
This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening/Baseline Period (4 weeks) and a Dosing/Observation Period (planned duration of 5 years, including a 52-week primary trea...Afficher plus
Titre officiel

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.

Pathologies
Fibrose du foieLiver Fibrosis in Chronic Hepatitis B
Autres identifiants de l'étude
  • KDN-F351-202501
Numéro NCT
NCT07412236
Date de début (réel)
2026-01-30
Dernière mise à jour publiée
2026-02-17
Date de fin (estimée)
2028-12-30
Inscription (estimée)
1 208
Type d'étude
Interventionnel
PHASE
Phase III
Statut
Pas encore en recrutement
Mots clés
LIver Fibrosis in Chronic Hepatitis B
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalHydronidone Capsule Group (270 mg)
Treatment Group
Hydronidone (270mg)
Dosage: 30 mg/capsule, three capsules taken three times daily, resulting in a total daily therapeutic dose of 270 mg. The medication is administered orally half an hour before meals.
Comparateur placeboHydronidone Capsule Group (Placebo Group)
Placebo Group
Hydronidone (Placebo Group)
Dosage: three capsules taken three times daily.The medication is administered orally half an hour before meals.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Incidence of Clinical Endpoint Events
The clinical endpoint event is a composite event, which includes progression to complications of decompensated cirrhosis (such as ascites, esophageal and gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy, etc.), hepatocellular carcinoma, liver transplantation, and liver disease-related death/all-cause death. The time of event occurrence is determined by whichever occurs first, and the occurrence of any of these events constitutes a clinical endpoint event.
From the first dose administration to the end of the treatment period (Week 261).
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Annualized Incidence Rate of Clinical Endpoint Events
From the first dose administration to the end of the treatment period (Week 261).
The incidence rates of individual components of the clinical endpoint events
From the first dose administration to the end of the treatment period (Week 261).
The annualized incidence rates of individual components of the clinical endpoint events
From the first dose administration to the end of the treatment period (Week 261).
Change from baseline in liver stiffness measurement (LSM) by transient elastography (kPa) after treatment.
From the first dose administration to the end of the treatment period (Week 261).
Undetectable rate of Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment (below the lower limit of detection).
From the first dose administration to the end of the treatment period (Week 261).
Magnitude of reduction in Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment.
From the first dose administration to the end of the treatment period (Week 261).
Magnitude of improvement in alanine aminotransferase (ALT) levels after treatment.
From the first dose administration to the end of the treatment period (Week 261).
Normalization rate of improvement in alanine aminotransferase (ALT) levels after treatment.
From the first dose administration to the end of the treatment period (Week 261).
Normalization rate of improvement in aspartate aminotransferase (AST) levels after treatment.
From the first dose administration to the end of the treatment period (Week 261).
Magnitude of improvement in aspartate aminotransferase (AST) levels after treatment.
From the first dose administration to the end of the treatment period (Week 261).
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous

  • Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;

  • Documented history of chronic hepatitis B and/or positive for hepatitis B surface antigen (HBsAg) for ≥6 months;

  • Treatment-naïve or treatment-experienced patients with chronic hepatitis B, defined as follows:

    1. Treatment-naïve patients must meet all of the following criteria:

      • No prior systemic antiviral therapy (e.g., interferon and/or nucleos(t)ide analogues) before randomization;
      • Positive for HBV DNA;
      • Liver stiffness measurement (LSM) by transient elastography ≥12.4 kPa for treatment-naïve patients with ALT >2 × ULN; or LSM ≥10.6 kPa for treatment-naïve patients with ALT ≤2 × ULN. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.

    2. Treatment-experienced patients must meet all of the following criteria:

      • A history of ≥6 months of continuous nucleos(t)ide analogue therapy for hepatitis B up to randomization, currently receiving monotherapy with a nucleos(t)ide analogue \[e.g., Tenofovir Alafenamide Fumarate (TAF), Tenofovir Disoproxil Fumarate (TDF), or Entecavir (ETV)\];
      • HBV DNA positive or negative is acceptable;
      • Liver stiffness measurement (LSM) by transient elastography >9.0 kPa. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.

  • ALT <8 × ULN;

  • No use within 3 months prior to randomization of the following Chinese patent medicines that may have antifibrotic effects: Fuzhenghuayu Capsule (Tablet), Anluohuaxian Pill, Compound Biejia Ruangan Tablet, etc.;

  • Subjects (or their sexual partners) have no pregnancy plan during the trial and for 6 months after trial completion, voluntarily agree to use effective physical contraceptive methods, and have no plan to donate sperm or eggs;

  • Subjects have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to participation, voluntarily agree to take part in this clinical trial, are able to communicate well with the investigators, agree to comply with all study requirements, and have provided written informed consent.

  • Total bilirubin (TBil) >3 × ULN, or 3 × ULN < ALT <8 × ULN with TBil >2 × ULN;
  • Platelet count (PLT) ≤50 × 10⁹/L;
  • Prothrombin activity (PTA) <50% or International Normalized Ratio (INR) >1.5;
  • Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) >100 μg/L even in the absence of specific signs of hepatocellular carcinoma;
  • Patients with decompensated liver cirrhosis (complications including ascites, esophageal and/or gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy) or with hepatic malignancy;
  • Patients with chronic hepatitis C or non-viral chronic hepatitis (alcoholic, drug-induced, etc., excluding metabolic dysfunction-associated steatotic liver disease (MASLD));
  • History of alcohol abuse or inability to abstain from alcohol recently \[Note: Alcohol abuse is defined as: ① daily ethanol consumption ≥40 g for males or ≥20 g for females for 5 consecutive years; OR ② history of heavy alcohol consumption (\>80 g of ethanol per day) within the past 2 weeks. Ethanol (g) = volume of alcoholic beverage consumed (mL) × alcohol by volume (%) × 0.8\];
  • Patients with severe concurrent cardiovascular, pulmonary, renal, endocrine, neurological, or hematological diseases, or psychiatric disorders;
  • Pregnant and/or lactating women;
  • Participation in any other drug clinical trial within the past 3 months;
  • Any condition that, in the investigator's judgment, may affect the subject's ability to provide informed consent or comply with the trial protocol, or participation that may affect the trial results or the subject's own safety.
Beijing Continent Pharmaceutical Co, Ltd. logoGyre Therapeutics
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine logoShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact central de l'étude
Contact: Ling Zhang, +86-13501209210, [email protected]
1 Centres de l'étude dans 1 pays
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Lungen Lu, Dr, Contact