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

Primary Purpose

Hepatitis B Virus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tenofovir alafenamide Fumarate
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B Virus focused on measuring hepatitis B virus, nucleoside, nucleotide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

TAF group

Observation group

Arm Description

50 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long.

50 patients would not receive treatment from baseline to life-long.

Outcomes

Primary Outcome Measures

hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value

Secondary Outcome Measures

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.
hepatitis b virus(HBV) DNA undetectable rate
Hepatitis b virus DNA would not be detected if it below the upper limit of test value
hepatitis b virus(HBV) RNA undetectable rate
Hepatitis b virus RNA would not be detected if it below the upper limit of test value

Full Information

First Posted
January 13, 2020
Last Updated
November 26, 2021
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04231565
Brief Title
Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
Acronym
ALTHBV
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus
Keywords
hepatitis B virus, nucleoside, nucleotide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAF group
Arm Type
Active Comparator
Arm Description
50 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long.
Arm Title
Observation group
Arm Type
No Intervention
Arm Description
50 patients would not receive treatment from baseline to life-long.
Intervention Type
Drug
Intervention Name(s)
Tenofovir alafenamide Fumarate
Other Intervention Name(s)
Vemlidy
Intervention Description
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Primary Outcome Measure Information:
Title
hepatitis b s antigen loss rate
Description
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value
Time Frame
144 week
Secondary Outcome Measure Information:
Title
hepatitis b e antigen loss rate
Description
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
Time Frame
0 week,12 week,24 week,36 week,48 week,72 week,96 week,120 week,144 week
Title
hepatitis b virus(HBV) DNA undetectable rate
Description
Hepatitis b virus DNA would not be detected if it below the upper limit of test value
Time Frame
0 week,12 week,24 week,36 week,48 week,72 week,96 week,120 week,144 week
Title
hepatitis b virus(HBV) RNA undetectable rate
Description
Hepatitis b virus RNA would not be detected if it below the upper limit of test value
Time Frame
0 week,12 week,24 week,36 week,48 week,72 week,96 week,120 week,144 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Wang, Doctor
Phone
+8618814369232
Email
wanglu910525@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following the article publication.
IPD Sharing Access Criteria
Proposals should be directed to xxx@yyy. To gain access, data requestors need to sign a data access agreement.
Citations:
PubMed Identifier
35435091
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.
Results Reference
derived
PubMed Identifier
35366805
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.
Results Reference
derived
PubMed Identifier
34408049
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.
Results Reference
derived

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

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