A Real-World Study on the Efficacy and Safety of Pradefovir Mesylate Tablets in the Treatment of Chronic Hepatitis B

A Real-World Study on the Efficacy and Safety of Pradefovir Mesylate Tablets in the Treatment of Chronic Hepatitis B: A Multicenter, Ambispective Cohort Study

This study is a multicenter, ambidirectional cohort real-world study initiated by the First Affiliated Hospital of Zhengzhou University, aiming to evaluate the efficacy and safety of Pradefovir Mesylate Tablets in the treatment of chronic hepatitis B (CHB).

Study Overview

• Status: Active, not recruiting
• Conditions: HEPATITIS B CHRONIC

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

treatment-naive/treatment-experienced patients with chronic hepatitis B

Description

Inclusion Criteria:

• (1) Aged 18 to 65 years (inclusive), regardless of gender; (2)Meet the diagnostic criteria for chronic hepatitis B (with documented HBsAg or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy) and test positive for HBsAg, HBeAg, and anti-HBc simultaneously; (3)Fulfill the indications for antiviral therapy as per the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)": ① Serum HBV DNA positive, with persistently abnormal ALT (> ULN), and other causes ruled out; ② Serum HBV DNA positive individuals, regardless of ALT levels, are recommended for antiviral therapy if they meet any of the following criteria: I. Family history of hepatitis B-related cirrhosis or HCC; II. Age >30 years; III. Non-invasive indicators or histologic examination suggesting significant liver inflammation (G≥2) or fibrosis (F≥2); IV. HBV-related extrahepatic manifestations (e.g., HBV-associated glomerulonephritis); ③ Clinically diagnosed compensated hepatitis B cirrhosis patients. (4)No restriction on treatment-naïve or treatment-experienced patients; (5)Agreement to use effective non-pharmacological contraceptive measures during the trial; (6)Agreement to participate in this clinical trial and voluntary signing of the informed consent form.

Exclusion Criteria:

• (1) Evidence suggestive of hepatocellular carcinoma (HCC) or serum alpha-fetoprotein (AFP) >100 μg/L; (2)Presence of signs indicating significant hepatic decompensation, such as ascites, hepatic encephalopathy, or esophageal/gastric variceal bleeding; (3)Platelet count (PLT) <30×10⁹/L, or hemoglobin (Hb) <100 g/L, or albumin (ALB) <30 g/L, or total bilirubin (TBIL) >2.5×upper limit of normal (ULN); (4)Co-infection with hepatitis C or D virus, HIV, autoimmune hepatitis, or other causes of active hepatitis; (5)History of allergy to nucleos(t)ide analogues, or documented resistance to nucleos(t)ide analogues; (6)Severe cardiopulmonary dysfunction, advanced malignancy, central nervous system disorders (e.g., history of epilepsy), or other systemic diseases; (7)Neurological or psychiatric disorders that preclude cooperation or willingness to cooperate; (8)Pregnancy, lactation, or planning pregnancy in the near future; (9)Inability or unlikelihood to complete the 2-year follow-up after enrollment; (10)Use of strong or moderate CYP3A4 or P-gp inhibitors (e.g., ketoconazole, erythromycin, itraconazole) or strong CYP3A4 or P-gp inducers (e.g., rifampicin, phenytoin sodium) within the past 3 months or currently taking such medications; (11)Other reasons deemed by the investigator as unsuitable for participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Experimental Group; Pradefovir Mesylate Tablet was administered orally at a dose of 45 mg once daily.
Control Group; Orally administered other NAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hepatitis B virus DNA levels	virological response (VR): Undetectable hepatitis B virus DNA levels,	From enrollment to the end of treatment at 48 weeks

Collaborators and Investigators

• Sponsor: Juan Li

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: JHSPLFW2506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED