A multicentric randomised controlled clinical trial of lamivudine,lamivudine plus adefovir and glycyrrhizin plus adefovir in HBV related decompensated cirrhosis

Indian Council of Medical Research0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Inclusion Criteria
•Patients will be eligible for the trial if all the following criteria are satisfied
•·Only naïve patients
•·Age > 16 years
•·HBsAg positive with HBV DNA positivity by PCR
•·Child?s score of ³ 7 but less than 13
•·Anti-HCV negativity
•·Willing to give blood specimens at baseline, 4 weekly during treatment period of 18 months and willing to come to the clinic for the clinical examinations and assessment for other complications
•·Willing to be treated for 18 months
•·No hepatocellular carcinoma at the time of inclusion, as shown by dual phase CECT

•A patient would not be eligible for inclusion, if he/she has any of the following:
•·Active alcohol abuse over last 6 months or more than 40gms per week.
•·Presence of associated co-infection with HCV, HDV, HEV, HAV, or HIV.
•·Presence of any one of the following at inclusion:
•oActive bleed or
•oHepatorenal syndrome (defined if 24 hr urine output is less than 500 ml despite 1.5 L of IV fluid infusion in 24 hrs, with a serum creatinine of > 1.5 mg/dl and no evidence of primary renal disease or obstructive uropathy). Patient could be included once the above complications are treated.
•·Presence of IgM HEV or IgM HAV as a cause of decompensation. Patient would be taken up once the episode subsides.
•·Associated metabolic liver diseases like Wilson?s disease, Hemochromatosis and Autoimmune liver disease.
•·Associated life threatening systemic disease.
•·Presence of HCC or hepatic venous outflow tract obstruction as demonstrated by imaging
•·Elevated Serum creatinine level > 1.5 mg/dl documented at least twice at 1 week interval in the last 3 months.
•·Any stage of encephalopathy at the time of inclusion will be excluded. (Once hepatic encephalopathy improves patient can be included in the study)
•·History of consumption of known hepatotoxic alternative drugs, during previous 6 months.

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