NCT04231565

Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatitis B Virus

Interventions

Type	Name	Description
DRUG	Tenofovir alafenamide Fumarate	Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.

Timeline

• Start date: 2020-06-04
• Primary completion: 2024-06-01
• Completion: 2027-07-01
• First posted: 2020-01-18
• Last updated: 2024-03-01

Locations

1 site across 1 country: China