A clinical trial to test the efficacy of Adefovir alone, and in combination with lamivudine /glycyrrhizin in decompensated liver disease due to hepatitis B.

Phase 3

Registration Number: CTRI/2008/091/000185

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 300

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

Exclusion Criteria

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
oSepsis 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in CTP at the end of treatment.<br><br>End of treatment response would be considered successful if CTP improvement at the end of treatment improves by 2 score (successful end of treatment response or SETR).<br><br>Failure of therapy ? If at the end of treatment CTP does not improve.<br><br>Timepoint: All above parameters at the end of treatment

Secondary Outcome Measures

Name	Time	Method
·Clinical response <br>Frequency of death in each treatment group.<br>Frequency of HCC in each treatment group<br>Frequency of complications (Variceal bleed, SBP, HRS) in each group.<br><br>·Virological response <br>End of treatment response: assessed by demonstrating HBeAg seroconversion in e +ve cases or at least 1 log reduction in HBV DNA load in e ?ve cases at the end of treatment.<br><br>Failure of virological response: assessed by demonstrating the persistence of HBeAg and no reduction in the HBV DNA load at the end of treatment.<br><br>·Biochemical response: <br>End of treatment response<br>Improvement of serum albumin and prothrombin time above the baseline value.<br><br>Timepoint: at the end of treatment