Clinical trial NCT04231565: Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis B Virus
Keywords: hepatitis B virus
nucleoside
nucleotide
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: hepatitis b s antigen decrease from baseline
timeFrame: 48 week, 96 week, 144 week
Secondary outcomes:
measure: hepatitis b e antigen loss rate
timeFrame: 48 week, 96 week, 144 week
measure: hepatitis b virus(HBV) DNA undetectable rate
timeFrame: 48 week, 96 week, 144 week
measure: hepatitis b virus(HBV) RNA undetectable rate
timeFrame: 48 week, 96 week, 144 week
measure: hepatitis b s antigen loss rate
timeFrame: 48 week, 96 week, 144 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang L, Zhu S, Liu Y, Zheng L, Xu W, Luo Q, Zhang Y, Deng H, Li X, Xie C, Peng L. Prognostic value of decline in model for end-stage liver disease score and hepatic encephalopathy in hepatitis B-related acute-on-chronic liver failure patients treated with plasma exchange. Scand J Gastroenterol. 2022 Sep;57(9):1089-1096. doi: 10.1080/00365521.2022.2063032. Epub 2022 Apr 17.
citation: Wang L, Xu W, Li X, Chen D, Zhang Y, Chen Y, Wang J, Luo Q, Xie C, Peng L. Long-term prognosis of patients with hepatitis B virus-related acute-on-chronic liver failure: a retrospective study. BMC Gastroenterol. 2022 Apr 2;22(1):162. doi: 10.1186/s12876-022-02239-4.
citation: Wang L, Wu L, Li X, Zhang Y, Lai J, Zhu X, Xie C, Peng L. Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 18;11(8):e048410. doi: 10.1136/bmjopen-2020-048410.