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

NCT04643990 | Unknown

• 1 other identifier: 0000000
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• HBV DNA

  Hepatitis B virus DNA is double-deoxyribonucleotide, which is a marker of hepatitis B virus replication.

  6 and 12 months

Secondary Outcomes (2)

• HBeAg seroconversion rate

  3,6,9,and 12 months

• Estimated glomerular filtration rate

  3,6,9,and 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• Patients had no obvious heart, lung and other important organ diseases in the past;
• Patients have sign the informed consent form and complied with the study medication and follow-up plan.

You may not qualify if:

• Co-infectious with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV;
• In the decompensated stage of liver cirrhosis, such as ascites, varicose bleeding or hepatic encephalopathy;
• With malignant tumors (including hepatocellular carcinoma);
• 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;
• During the study period, chronic systemic steroid drugs are required or may be used under any medical conditions;

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Ermei Li

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chaoshuang Lin, Professor

  Third Sun Yat Sen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaoshuang Lin, Professor

CONTACT

+8613794365980; linchaoshuang@126.com

Ermei Li, Student

CONTACT

+8613723583617; liermei2020@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Lin

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 25, 2020
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 1, 2022
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

CN (1)