Health Condition 1: K739- Chronic hepatitis, unspecified
Conditions
Interventions
Intervention1: Arm 1. Stop nucleotide: In this arm, No drugs for hepatitis B virus will be given after randomisation. oral nucleos(t) will be stopped
Control Intervention1: Arm 2. Continue nucleos(t)i
Sponsors
Dr Shalimar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-cirrhotic chronic hepatitis B infected patients who are on nucleotide analogue therapy with undetectable HBV DNA for the last 3 years 2. Age between 18-65 years 3. Willing to participate
Exclusion criteria
Exclusion criteria: 1. Presence of cirrhosis or significant fibrosis (LSM > 8 kPa) 2. Decompensated cirrhosis 3. Pregnant women 4. Co-infection with hepatitis C virus or HIV 5. Hepatocellular carcinoma 6. Detectable DNA in last 3 years 7. Immunocompromised status requiring continuous nucleotide treatment 8. Non compliant to medication in 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the difference in the HBsAg loss among HBV patients who continue nucleos(t)ide therapy compared to those who stop therapy.Timepoint: Every 4 weekly for 3 months then every monthly for 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Predictors of persistent virological responseTimepoint: 24 months;Proportion of patients developing biochemical flareTimepoint: 24 months;Proportion of patients developing clinical flareTimepoint: 24 months;To compare the proportion of patients achieving HBsAg seroconversion (Anti-HBsAb positive).Timepoint: 24 months;To compare the proportion of patients with negative HBV DNATimepoint: 24 months | — |
Countries
India
Contacts
Public ContactDr Shalimar
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed