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
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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
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