Analysis of Renal Impairment Characteristics and High-Risk Factors in Chronic Hepatitis B Patient… (NCT07730905) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Renal Impairment Characteristics and High-Risk Factors in Chronic Hepatitis B Patients on Long-Term Oral Nucleos(t)Ide Analogues
China300 participantsStarted 2024-09-04
Plain-language summary
This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included. We collect clinical data, laboratory indicators and imaging results, and analyze the correlation between long-term nucleoside antiviral drugs and renal function changes in patients. The study does not use any new intervention measures, and only conducts statistical analysis on existing medical record data.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Meet the diagnostic criteria for chronic hepatitis B specified in the 2019 Chinese Society of Infectious Diseases guidelines.
. Patients received continuous NAS antiviral treatment for at least 12 months.
. Patients voluntarily participated in the study and signed informed consent.
. Complete records of liver function, renal function, urinary indicators and HBV-DNA data are available.
Exclusion criteria
. Combined with chronic nephritis, nephrotic syndrome and other primary kidney diseases.
. Co-infection with hepatitis C virus, hepatitis E virus and other hepatitis viruses.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum creatinine level
Timeframe: At baseline (the index assessment).
2
Estimated glomerular filtration rate
Timeframe: At baseline (the index assessment).
3
Blood urea nitrogen level
Timeframe: At baseline (the index assessment).
Trial details
NCT IDNCT07730905
SponsorFoshan Hospital of Traditional Chinese Medicine