LDT Combined With TDF to Improve EGFR Decreasing in Patients With Chronic Hepatitis B Treated With TDF

Clinical Analysis of LDT Combined With TDF to Improve EGFR Decreasing in Patients With Chronic Hepatitis B Treated With TDF

Chronic hepatitis B (CHB) is an important public health problem in the world. There are still more than 250 million chronic hepatitis B virus (CHB) infected people in the world. Its preventive effect has reached a relatively ideal effect, but its therapeutic effect still has great room for improvement.

Tenofovir(TDF) is the first-line antiviral treatment with good clinical efficacy. However, some patients who take TDF for a long time have different degrees of renal dysfunction, which limits the use of TDF in these patients.

Tenofovir Alafenamide Fumarate (TAF) has better plasma stability and stronger liver targeting, and reduces the side effects of renal function damage and bone mineral density reduction. Telbivudine (LDT), a nucleoside analogue, has the advantages of rapidly reducing HBV viral load and high HBeAg seroconversion rate.

In addition, prospective studies have shown that LDT can improve the estimated glomerular filtration rate (EGFR).Therefore, this study aims to explore the clinical study of LDT combined with TDF and TAF in patients treated with tenofovir and EGFR < 90ml / min / 1.72m².

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B

Detailed Description

This is a multi-center, open-label clinical study. This study was aimed to explore the LDT combined with TDF and TAF in patients treated with TDF and EGFR < 90ml / min / 1.72m².The primary objectives of this study is as follows: To access the effectiveness and safety of 12-month treatment with LDT combined with TDF and only TAF in patients with CHC and cirrhosis in real-world clinical practice in Southern area of China. The proportion of participants with HBV DNA (DNA:Hepatitis B virus deoxyribonucleic acid)was evaluated. This study aims to enroll 200 patients with CHB in each treatment group. Patients with CHB having received the TAF previously but EGFR < 90ml / min / 1.72m² subsequently fulfills the indication of antiviral therapy will be administered with LDT combined with TDF and only TAF treatment. After 12-month treatment, all the patients will be followed up for 12 months.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • Ermei Li
      • Contact: Ermei Li, Student; Phone Number: +8613723583617; Email: liermei2020@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Mainly patients with decreased glomerular filtration rate after taking TDF and meeting the above inclusion criteria and not meeting any of the appeal exclusion criteria.

Description

Inclusion Criteria:

1. After TDF treatment, patients with eGFR<90ml/min/1.72m² and without obvious renal damage before taking the medicine switch to LDT combined with TDF, or switch to TAF treatment;
2. Patients had no obvious heart, lung and other important organ diseases in the past;
3. Patients have sign the informed consent form and complied with the study medication and follow-up plan.

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;
6. 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LDT Combined with TDF for Treatment; The patients take one tablet of LDTand one tablet of TDF every night and continue to 12 months.
Only TAF treatment.; The patients take one tablet of TAF every night and continue to 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV DNA	Hepatitis B virus DNA is double-deoxyribonucleotide, which is a marker of hepatitis B virus replication.	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBeAg seroconversion rate	HBeAg seroconversion rate means that HBeAg cannot be detected in the patient's serum but HBeAb can be detected.	3,6,9,and 12 months
Estimated glomerular filtration rate	Estimating the glomerular filtration rate can roughly reflect the condition of kidney function.	3,6,9,and 12 months

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Chaoshuang Lin, Professor, Third Sun Yat Sen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: 0000000 (Sylvester Cancer Comprenhensive Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No