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Recruiting NCT04231565

NCT04231565 Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

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Clinical Trial Summary
NCT ID NCT04231565
Status Recruiting
Phase
Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Condition Hepatitis B Virus
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2020-06-04
Primary Completion 2024-06-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Tenofovir alafenamide Fumarate

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2020-06-04 with a primary completion date of 2024-06-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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.

Contact & Investigator

Central Contact

Qiumin Luo, Doctor

✉ lqiumin@126.com

📞 +8613632399075

Principal Investigator

Liang Peng, Doctor

PRINCIPAL INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Frequently Asked Questions

Who can join the NCT04231565 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hepatitis B Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04231565 currently recruiting?

Yes, NCT04231565 is actively recruiting participants. Contact the research team at lqiumin@126.com for enrollment information.

Where is the NCT04231565 trial being conducted?

This trial is being conducted at Guangzhou, China.

Who is sponsoring the NCT04231565 clinical trial?

NCT04231565 is sponsored by Third Affiliated Hospital, Sun Yat-Sen University. The principal investigator is Liang Peng, Doctor at Third Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 200 participants.

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