Status:
UNKNOWN
Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
Lead Sponsor:
Cttq
Conditions:
Chronic Hepatitis b
Liver Inflammation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 b...
Detailed Description
Chronic hepatitis B(HBV) has a high prevalence (\>8%) in China. Entecavir, aguanosine analog, is a potent and selective inhibitor of HBV DNA polymerase. Glycyrrhizin has been used for more than 30 ye...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2020
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT03349008
Start Date
November 25 2017
End Date
May 31 2020
Last Update
November 21 2017
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