TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for 12 Months

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Tenofovir Disoproxil Fumarate 300 MG; Drug: TDF

• Registration Number: NCT04650828
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment.

Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.

Detailed Description

This is an open, multicenter, exploratory and real-world clinical study. It will be carried out in patients with poor response (HBV DNA \> 2x103iu / ml) to tenofovir for 12 months. After one -week screening period, patients will be randomly assigned 1:1 to control and experimental groups. The control group takes tenofovir for 12 months while the experimental group takes tenofovir combined with telbivudinefor 12months .

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-11-24
• Study Start: 2020-12-01
• Study First Posted: 2020-12-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Co-infectious with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV;
2. In the decompensated stage of liver cirrhosis, such as ascites, varicose bleeding or hepatic encephalopathy;
3. With malignant tumors (including hepatocellular carcinoma);
4. Concomitant with other liver diseases, such as alcoholic liver disease, autoimmune disease, or other systemic diseases involving the liver, such as hemochromatosis, Alpha-1 antitrypsin deficiency, or Wilson disease;
5. During the study period, chronic systemic steroid drugs are required or may be used under any medical conditions;

There are any other factors that the researcher thinks are not suitable for inclusion in the study, or that may affect the patient's participation or completion of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active comparator:person with TDF	Tenofovir Disoproxil Fumarate 300 MG	TDF monotherapy was continued for 12 months
Experimental:person with TDF+LDT	TDF	TDF combined with LDT for 12 months

Primary Outcome Measures

Name	Time	Method
HBeAg seroconversion rates	24months	HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment

Secondary Outcome Measures

Name	Time	Method
HBeAg negative rate	12 and 24months	HBeAg negative rate of tenofovir combined with telbivudine treatment at 12 and 24 months
Renal function index	12 and 24months	Renal function index of tenofovir combined with telbivudine treatment at 12 and 24 months
ALT normalization rate	12 and 24months	ALT normalization rate of tenofovir combined with telbivudine treatment at 12 and 24 months

Trial Locations

Locations (1)

Chaoshuang Lin; 🇨🇳 Guangzhou, China