The purpose of this study is to determine whether vitamin D is effective in the prevention of
hepatocellular carcinoma in those patients with chronic hepatitis B.
Drug: Vitamin D3
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02779465
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
All subjects between the ages of 18 and 70 with chronic hepatitis B and under the oral anti-virus treatment followed at the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, will be offered entry into this study. The diagnosis of chronic Hepatitis B will be based on that they had been positive for hepatitis B surface antigen (HBsAg) for at least six months, and were positive for HBeAg or negative for HBeAg with detectable HBV DNA at screening.
No evidence of HCC on entry imaging study.
Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).
Not currently participating in another intervention study.
Not pregnant or lactating, and willing to use effective contraception during study period.
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Ability to provide written informed consent according to national/local regulations.
evidence of hepatocellular carcinoma within 6 months after enrollment,
a serum alanine aminotransferase level more than 10 times the upper limit of normal,
an elevated serum creatinine level,
any diagnosis of kidney stones,
a diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years,
any evidence of autoimmune hepatitis, coinfection with hepatitis C or D virus or human immunodeficiency virus,
other serious concurrent illness (e.g., alcoholism, uncontrolled diabetes, or cancer),
treatment with immunomodulatory within the 6 months before screening,
treatment with any investigational drug within the 30 days before the study began.
All locations for NCT02779465
View full eligibility
Tris trial is registered with FDA with number: NCT02779465. The sponsor of the trial is Third Affiliated Hospital, Sun Yat-Sen University and it is looking for 1500 volunteers for the current phase.
Official trial title: Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Thank you for applying!
We'll contact you soon with more information.
Consult your doctor?
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.