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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650828
• Other study ID #: 00000001
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2021
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. Male or female patients, aged 18 to 70 years, including 18 and 70 years old;

2. Patients with poor response to tenofovir for 12 months did not obtained HBeAg seroconversionPatients with poor response to tenofovir for 12 months who didn't obtain HBeAg seroconversion choosed to continue taking tenofovir or take tenofovir combined with Tbl for 12months;

3. Persons were willing to sign informed consent and comply with medication regimen and follow-up.

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• TDF
TDF combined with telbivudine (LDT) for 12 months
• Tenofovir Disoproxil Fumarate 300 MG
TDF monotherapy was continued for 12 months

Locations

Country	Name	City	State
China	Chaoshuang Lin	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg seroconversion rates	HBeAg seroconversion rates at 12 months after tenofovir plus telbivudine treatment	12months
Primary	HBeAg seroconversion rates	HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment	24months
Secondary	HBeAg negative rate	HBeAg negative rate of tenofovir combined with telbivudine treatment at 12 and 24 months	12 and 24months
Secondary	ALT normalization rate	ALT normalization rate of tenofovir combined with telbivudine treatment at 12 and 24 months	12 and 24months
Secondary	Renal function index	Renal function index of tenofovir combined with telbivudine treatment at 12 and 24 months	12 and 24months