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Understanding the Link Between HBV RNA and Hepatitis B Surface Antigen Levels in Patients With Chronic Hepatitis B on or off Treatment

Prospective single centre observational study for correlation of HBV RNA with HBsAg quantitative levels in Chronic Hepatitis B patients with or without NUCs with undetectable viral DNA HOPE STUDY - HOPE Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/087385
Enrollment
180
Registered
2025-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B180- Chronic viral hepatitis B with delta-agent

Interventions

Intervention1: Nil: Nil

Sponsors

Nanavati Max Institute of Liver Intestine and Pancreas Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Participants willing and able to provide informed consent prior to any study specific procedures being performed 2 Men and women 18 years of age or older inclusive based on the date of the screening visit 3 Patients with chronic hepatitis B on treatment with NUCs with undetectable HBV DNA levels for atleast 1 year OR Patients with Chronic Hepatitis B not on treatment with NUCs

Exclusion criteria

Exclusion criteria: 1 Liver cirrhosis 2 Undetectable levels of HBV DNA Quantitative for less than a year in patients who are on NUCs 3 Presence of HIV HCV or HDV on Medical history which might influence HBV Progression 4 Evidence of Hepatocellular Carcinoma

Design outcomes

Primary

MeasureTime frame
The study will evaluate HBV RNA levels in patients with varying HBsAg quantitative levels to identify the subset of patients with low HBsAg less than 100 IU per mL and undetectable HBV RNA.Timepoint: The study will evaluate HBV RNA levels in patients with varying HBsAg quantitative levels to identify the subset of patients with low HBsAg less than 100 IU per mL and undetectable HBV RNA.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Samir R Shah

Nanavati Max Institute of Liver Intestine and Pancreas Sciences

drshahsamir@gmail.com9820144338

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026