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

NCT07555340 | Active Not Recruiting

• 1 other identifier: JHSPLFW2506
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HEPATITIS B CHRONIC

Outcome Measures

Primary Outcomes (1)

• hepatitis B virus DNA levels

  virological response (VR): Undetectable hepatitis B virus DNA levels,

  From enrollment to the end of treatment at 48 weeks

Study Arms (2)

Experimental Group

Pradefovir Mesylate Tablet was administered orally at a dose of 45 mg once daily.

Control Group

Orally administered other NAs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Juan Li: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician, Associate Professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 29, 2026
• Study Start: December 30, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-10

Locations

CN (1)