Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04231565
Other study ID # PL10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 4, 2020
Est. completion date July 1, 2027

Study information

Verified date February 2024
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Qiumin Luo, Doctor
Phone +8613632399075
Email lqiumin@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.


Description:

Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 1, 2027
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Positive hepatitis b surface antigen and hepatitis b antibody > 0.5 year; - Age from 18 to 65 years old; - Serum Alanine Aminotransferase(ALT) =1×ULN at least 12 weeks; - Positive Hepatitis b virus(HBV); - Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year. Exclusion Criteria: - Other active liver diseases; - Hepatocellular carcinoma or other malignancy; - Pregnancy or lactation; - Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir alafenamide Fumarate
Patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF)once per day.

Locations

Country Name City State
China Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

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 hepatitis b s antigen decrease from baseline Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144. 48 week, 96 week, 144 week
Secondary hepatitis b e antigen loss rate Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen. 48 week, 96 week, 144 week
Secondary hepatitis b virus(HBV) DNA undetectable rate Hepatitis b virus DNA would not be detected if it below the upper limit of test value 48 week, 96 week, 144 week
Secondary hepatitis b virus(HBV) RNA undetectable rate Hepatitis b virus RNA would not be detected if it below the upper limit of test value 48 week, 96 week, 144 week
Secondary hepatitis b s antigen loss rate Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value 48 week, 96 week, 144 week
See also
  Status Clinical Trial Phase
Completed NCT03459521 - Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease. N/A
Completed NCT02060162 - Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
Completed NCT00912847 - Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma N/A
Completed NCT04072211 - Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District Phase 4
Completed NCT01204762 - Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen Phase 2
Completed NCT00805675 - Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB Phase 3
Completed NCT02785835 - Hepatocellular Carcinoma in HIV-infected Patients
Completed NCT03083821 - A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting Phase 1
Recruiting NCT01083251 - The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic Hepatitis B Virus (HBV) Infection N/A
Not yet recruiting NCT05752890 - A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma
Terminated NCT00678587 - Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures Phase 3
Completed NCT00739752 - Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics N/A
Completed NCT03294798 - Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient Phase 1/Phase 2
Withdrawn NCT04385524 - Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection N/A
Enrolling by invitation NCT00663182 - Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis Phase 4
Completed NCT00769730 - Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication N/A
Completed NCT01438424 - Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials Phase 2
Withdrawn NCT04046107 - Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy Phase 1/Phase 2
Completed NCT05406089 - Effects of Antiviral Therapy on Patients With HBV-related HCC
Completed NCT03625258 - Mutations of the Pre-core Region of Hepatite B Virus (HBV)