Clinical trial NCT04650828: TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for 12 Months
Official title: TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for Twelve Months
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with poor response (HBV DNA \> 2x103iu / ml) to tenofovir for 12 months

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: HBeAg seroconversion rates
timeFrame: 12months
measure: HBeAg seroconversion rates
timeFrame: 24months
Secondary outcomes:
measure: HBeAg negative rate
timeFrame: 12 and 24months
measure: ALT normalization rate
timeFrame: 12 and 24months
measure: Renal function index
timeFrame: 12 and 24months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Chaoshuang Lin
Study officials:
References: