None listed
Conditions
Interventions
Intervention1: Adefovir 10 mgms: OD for 18 mths
Intervention2: Adefovir10mgs plus Lamivudine 100mgs: OD for 18 mths
Intervention3: Adefovir10mgsPlusglycyrrhizin 150 mgs: OD for 18 mths
Control Interve
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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
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: o Active bleed or o Sepsis or o Hepatorenal 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in CTP at the end of treatment. 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). Failure of therapy ? If at the end of treatment CTP does not improve. Timepoint: All above parameters at the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| · Clinical response Frequency of death in each treatment group. Frequency of HCC in each treatment group Frequency of complications (Variceal bleed, SBP, HRS) in each group. · Virological response 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. Failure of virological response: assessed by demonstrating the persistence of HBeAg and no reduction in the HBV DNA load at the end of treatment. · Biochemical response: End of treatment response Improvement of serum albumin and prothrombin time above the baseline value. Timepoint: at the end of treatment | — |
Countries
India
Contacts
Public ContactDr. Deepali Mukherji
ICMR
Outcome results
None listed