Hepatitis B VirusALTHBVNCT04231565
Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
A study testing Tenofovir alafenamide Fumarate in people with Hepatitis B Virus, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B Virus
- What is being tested?
- Tenofovir alafenamide Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2020to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
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
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.
Read the 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
- Being tested
- Tenofovir alafenamide Fumarate
- Keywords
- hepatitis B virus, nucleoside, nucleotide
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir alafenamide FumarateDrug
Also called Vemlidy
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
| Study group | Role | What they receive |
|---|---|---|
| TAF group | Active comparator | 100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss. Receives: Drug: Tenofovir alafenamide Fumarate |
| Observation group | No intervention | 100 patients would not receive treatment from baseline to life-long. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatitis b s antigen decrease from baseline
Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.
Measured: 48 week, 96 week, 144 week
Secondary outcomes (4)
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.
Measured: 48 week, 96 week, 144 week
hepatitis b virus(HBV) DNA undetectable rate
Hepatitis b virus DNA would not be detected if it below the upper limit of test value
Measured: 48 week, 96 week, 144 week
hepatitis b virus(HBV) RNA undetectable rate
Hepatitis b virus RNA would not be detected if it below the upper limit of test value
Measured: 48 week, 96 week, 144 week
hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value
Measured: 48 week, 96 week, 144 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 Jun 2020
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231565
- Sponsor's protocol ID
- PL10
- Acronym
- ALTHBV
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.
Publications
Luo Q, Xu R, Zhang Y, Xu W, Li X, Lai J, Li J, Zheng X, Deng H, Chen L, Zhu X, Xie C, Peng L. Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Virus Infection in the High-Replicative Low-Inflammatory Phase: A 48-Week Randomized Controlled Trial. J Med Virol. 2026 May;98(5):e70960. doi: 10.1002/jmv.70960.
PubMed 42095461Luo Q, Xu W, Zhang Y, Li X, Lai J, Li J, Zheng X, Deng H, Chen L, Zhu X, Xie C, Peng L. Tenofovir Alafenamide Fumarate Reduces Virological Replication in HBeAg-Negative Patients With Normal Alanine Aminotransferase: A 48-Week Randomised Controlled Trial. J Viral Hepat. 2026 Mar;33(3):e70141. doi: 10.1111/jvh.70141.
PubMed 41608776Wang 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.
PubMed 35435091Wang 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.
PubMed 35366805Wang 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.
PubMed 34408049
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04231565
- Acronym / sponsor ID
- ALTHBV / PL10
- Conditions
- Hepatitis B Virus
- Keywords
- hepatitis B virus, nucleoside, nucleotide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAF group | Active comparator | Drug: Tenofovir alafenamide Fumarate100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss. |
| Observation group | No intervention | –100 patients would not receive treatment from baseline to life-long. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir alafenamide FumarateAlso: VemlidyPatients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day. | Drug | TAF group |
Primary outcome
hepatitis b s antigen decrease from baseline
Time frame: 48 week, 96 week, 144 week
Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.
4 secondary outcomes
hepatitis b e antigen loss rate
Time frame: 48 week, 96 week, 144 week
hepatitis b virus(HBV) DNA undetectable rate
Time frame: 48 week, 96 week, 144 week
hepatitis b virus(HBV) RNA undetectable rate
Time frame: 48 week, 96 week, 144 week
hepatitis b s antigen loss rate
Time frame: 48 week, 96 week, 144 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 42095461Luo Q, Xu R, Zhang Y, Xu W, Li X, Lai J, Li J, Zheng X, Deng H, Chen L, Zhu X, Xie C, Peng L. Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Virus Infection in the High-Replicative Low-Inflammatory Phase: A 48-Week Randomized Controlled Trial. J Med Virol. 2026 May;98(5):e70960. doi: 10.1002/jmv.70960.
- Derived from this study: PubMed 41608776Luo Q, Xu W, Zhang Y, Li X, Lai J, Li J, Zheng X, Deng H, Chen L, Zhu X, Xie C, Peng L. Tenofovir Alafenamide Fumarate Reduces Virological Replication in HBeAg-Negative Patients With Normal Alanine Aminotransferase: A 48-Week Randomised Controlled Trial. J Viral Hepat. 2026 Mar;33(3):e70141. doi: 10.1111/jvh.70141.
- Derived from this study: PubMed 35435091Wang 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.
- Derived from this study: PubMed 35366805Wang 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.
- Derived from this study: PubMed 34408049Wang 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang Peng, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir alafenamide Fumarate in people with Hepatitis B Virus, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiumin Luo, Doctor (+8613632399075, lqiumin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatitis b s antigen decrease from baseline (time frame: 48 week, 96 week, 144 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231565, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.