Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients

Not yet recruiting

• Conditions: Chronic Hepatitis B Patients

• Registration Number: NCT05991531
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-06
• Study First Posted: 2023-08-14
• Study Start: 2023-08-15
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-08-15
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.18 years old or above and the gender is not limited;
• 2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
• 3. Patients with HBV DNA negative (HBV DNA<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
• 4. Good compliance and voluntary signing of informed consent.

Exclusion Criteria

• 1. Patients with decompensated cirrhosis;
• 2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
• 3. Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
• 4. Patients have active or suspected malignancy or history of malignancy;
• 5. Patients who were identified not appropriate for the study by investigators.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The decrease of HBV RNA from baseline to 48 weeks	2023.8-2025.8	The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;

Secondary Outcome Measures

Name	Time	Method
The association of HBV RNA changes with the liver stiffness;	2023.8-2025.8	During 48 weeks of treatment, the investigators detect the association of HBV RNA changes with the liver stiffness;
HBV RNA undetectable rate at 48 weeks;	2023.8-2025.8	After 48 weeks of treatment after enrollment, the investigators detect the HBV RNA undetectable rate 48 weeks;
The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;	2023.8-2025.8	During 48 weeks of treatment, the investigators detect the association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China