A trial to assess the effect of stopping antiviral drugs in patients without cirrhosis on hepatitis B surface antigen clearance
Phase 3
- Conditions
- Health Condition 1: K739- Chronic hepatitis, unspecified
- Registration Number
- CTRI/2021/05/033337
- Lead Sponsor
- Dr Shalimar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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