Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agent
Conditions
Interventions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged above 18 years of age, with inactive chronic hepatitis B (HB) or immune tolerant phase, with or without liver enzyme changes and having all of the following 1.HBsAg +ve for >6 months 2.Patientswhoarepositive forHBVwith increasedviral loadabove300 IU/mL 3.Not currently on antiviral therapy for Chronic hepatitis B or discontinued antiviral treatment for the last 3 months
Exclusion criteria
Exclusion criteria: ? Pregnant, lactatingwomen and Children ? Evidence of any other chronic liver disease ? Patient with hepatocellular carcinoma ? Coinfection with HIV,HCV ? Active substance or alcohol abuse and concurrent use of corticosteroids/NSAIDS or immunosuppressive agents ? Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above) ? Allergic to the drug ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary out come: ?Primary Outcome is mainly assessed by reduction in HBV viral load (Quantitative PCR) Timepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To evaluate the safety of the study drugs by assessing adverse events & laboratory investigations (viz., hemogram, liver function tests (LFT), renal function tests (RFT), lipid profile).Timepoint: one year | — |
Countries
India
Contacts
NATIONAL INSTITUTE OF SIDDHA