A Real-World Study on the Efficacy and Safety of Pradefovir Mesylate Tablets in the Treatment of … (NCT07555340) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Real-World Study on the Efficacy and Safety of Pradefovir Mesylate Tablets in the Treatment of Chronic Hepatitis B
China400 participantsStarted 2024-12-30
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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)": ①Serum 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 decompensati…
What they're measuring
1
hepatitis B virus DNA levels
Timeframe: From enrollment to the end of treatment at 48 weeks