Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir i… (NCT03349008) | Clinical Trial Compass
UnknownPhase 4
Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
480 participantsStarted 2017-11-25
Plain-language summary
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.
Who can participate
Age range
18 Years – 70 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:
* Hepatitis B surface antigen \[HBsAg\]-positive,
* Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody (HBeAb)-positive disease were eligible,
* Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum total bilirubin(TBIL)levels\<2×ULN
Exclusion Criteria:
* Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus;
* Other forms of liver disease;
* More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against HBV, and therapy with any anti-HBV drug within 24 weeks prior to randomization;
* More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin;
* Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC);
* During the study patients were not allowed to use other medicines.
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.