TAF (drug) for hepatitis B virus infectio

Not Applicable

• Conditions: Health Condition 1: K77- Liver disorders in diseases classified elsewhere

• Registration Number: CTRI/2022/01/039541
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. HBsAg+

2.Persistent normal ALT 3-6m apart ( <30 IU/ml in male and <20 IU/ml in female)

3.HBV DNA < 2000 IU/ml

4.LSM <8 Kpa

Exclusion Criteria

1.Prior NUC/IFN exposure.

2.Renal dysfunction (Serum Creatinine >1.5

mg/dl).

3.Known liver cirrhosis/ esophageal varices.

4.Any clinical decompensation (CD).

5.Pre-existing hepatocellular carcinoma.

6.Pregnancy

7.Healthcare workers (HCW).

8.Post transplant, patients with advance

malignancy or on chemotherapy.

9.Co-infections ââ?¬â?? Hepatitis C, Hepatitis D,

Human immunodeficiency virus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with HBV DNA less than 2000 IU/ml, normal ALT and no significant fibrosis (as per APASL 2015) <br/ ><br>Any two of the following ââ?¬â?? <br/ ><br>1.Significant fibrosis (LSM more than 8 Kpa or APRI more than 1.5) <br/ ><br>2.Persistently elevated ALT (2 consecutive ALT more than 30 U/ml 3-6m apart) <br/ ><br>3.HBV DNA more than 2000 IU/ml <br/ ><br>Timepoint: upto 5 years