Using Tenofovir Alafenamide to Prevent Liver Disease Progression in Chronic Hepatitis B
Official title: TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load - a Randomized Controlled Trial
Run by Institute of Liver and Biliary Sciences, India · NCT05195450 · Data updated 2026-11-12
This study is testing if a medication called Tenofovir Alafenamide can help people with chronic Hepatitis B who have normal liver function and low virus levels avoid worsening liver disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | February 23, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | February 28, 2022 |
| Trial ID | NCT05195450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are treatment-naïve individuals with non-cirrhotic chronic HBV infection, normal ALT levels, and low HBV viral loads.
✕Probably not a fit
Patients with prior antiviral treatment, liver cirrhosis, or co-infections such as Hepatitis C or HIV are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the safety and efficacy of Tenofovir Alafenamide (TAF) in patients with non-cirrhotic chronic Hepatitis B virus (HBV) infection who have normal ALT levels and low viral loads. It will be a prospective, randomized, open-label study conducted at the Institute of Liver and Biliary Sciences in New Delhi over a period of five years. Participants will be divided into two groups: one receiving TAF and the other receiving no treatment, with various assessments conducted throughout the study to monitor liver health and viral activity.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of liver disease progression and improve the quality of life for patients with chronic HBV infection.
How similar studies have gone: Previous studies have shown promising results with antiviral treatments for chronic HBV, suggesting that this approach may be effective, although the specific use of TAF in this context is less commonly tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- HBsAg+ * Persistent normal ALT 3-6m apart (\<30 IU/ml in male and \<20 IU/ml in female) * HBV DNA \< 2000 IU/ml * LSM \<8 Kpa Exclusion Criteria: * Prior NUC/IFN exposure * Renal dysfunction (Serum Creatinine \>1.5 mg/dl) * Known liver cirrhosis/ esophageal varices * Any clinical decompensation (CD) * Pre-existing hepatocellular carcinoma * Pregnancy * Healthcare workers (HCW) * Post transplant, patients with advance malignancy or on chemotherapy * Co-infections - Hepatitis C, Hepatitis D, Human immunodeficiency virus
Where it's running
-
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Study coordinator: Dr Ankur Jindal, DM
- Email: ankur.jindal3@gmail.com
- Phone: 01146300000
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.