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

NCT04650828 | Unknown DMC

• 1 other identifier: 00000001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• HBeAg seroconversion rates

  HBeAg seroconversion rates at 12 months after tenofovir plus telbivudine treatment

  12months

• HBeAg seroconversion rates

  HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment

  24months

Secondary Outcomes (3)

• HBeAg negative rate

  12 and 24months

• ALT normalization rate

  12 and 24months

• Renal function index

  12 and 24months

Study Arms (2)

Experimental:person with TDF+LDT

TDF combined with LDT for 12 months

Drug: TDF

Active comparator:person with TDF

TDF monotherapy was continued for 12 months

Drug: Tenofovir Disoproxil Fumarate 300 MG

Interventions

TDF DRUG

TDF combined with telbivudine (LDT) for 12 months

Experimental:person with TDF+LDT

Tenofovir Disoproxil Fumarate 300 MG DRUG

TDF monotherapy was continued for 12 months

Active comparator:person with TDF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with poor response (HBV DNA \> 2x103iu / ml) to tenofovir for 12 months

You may qualify if:

• Male or female patients, aged 18 to 70 years, including 18 and 70 years old;
• 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;
• Persons were willing to sign informed consent and comply with medication regimen and follow-up.

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)

Chaoshuang Lin

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Lin

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: December 3, 2020
• Study Start: December 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

CN (1)