NCT04231565Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 13 Jan 2020
- Start date
- 4 Jun 2020
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Hepatitis B
- NCT number
- NCT04231565
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 4 Jun 2020 to the primary completion date, 1 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- 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.
Other
- Pregnancy or lactation;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
Related publications
- 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 · PMID 42095461
- Tenofovir Alafenamide Fumarate Reduces Virological Replication in HBeAg-Negative Patients With Normal Alanine Aminotransferase: A 48-Week Randomised Controlled Trial.J Viral Hepat · 2026 · PMID 41608776
This page is information, not medical advice. Discuss any trial with your doctor.