Using Tenofovir Alafenamide to Prevent Liver Disease Progression in Chronic Hepatitis B
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT05195450 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New Delhi, National Capital Territory of Delhi
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.