Status:
RECRUITING
TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Non-cirrhotic, Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The main goal of therapy for patients with chronic HBV infection with no significant liver disease is to improve survival and quality of life by preventing disease progression, development of liver ci...
Detailed Description
Aim and Objective - To study the safety and efficacy of TAF as compared to initiation based on current criteria in patients with non-cirrhotic chronic HBV infection and normal ALT and low viral load. ...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05195450
Start Date
February 23 2022
End Date
December 31 2027
Last Update
February 28 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070