Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• • Age >18 years

• Chronic hepatitis B (HBsAg positive ≥ six months)

• HBeAg positive or negative

• ALT >19 for females and >30 for males (AASLD criteria)

• HBV DNA>4 log IU/mL for HBeAg positive and >3 log for HBeAg negative patients

• No oral antiviral treatment or IFN for ≥6 months

• Adequate contraception. For males, at least one method of contraception should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.

• Written informed consent

Exclusion Criteria:

• • Treatment with any investigational drug within 60 days of entry into this protocol

• Immune-suppressive treatment within the previous 6 months

• History of decompensated cirrhosis (defined as direct (conjugated)

• bilirubin > 1.2 × ULN,

• prothrombin time (PT) > 1.2 × ULN

• platelets < 100,000/mm3

• serum albumin < 3.5 g/dL

• prior history of clinical hepatic decompensation (jaundice in the presence of cirrhosis, ascites, gastric bleeding, oesophageal varices or encephalopathy)

• Liver transplantation

• Co-infection with hepatitis C virus, hepatitis D virus or HIV

• Other significant liver disease: alcoholic liver disease, drug-related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency

• Estimated glomerular filtration rate <50 mL/min/1.73m2 or any significant renal disease.

• Alpha-fetoprotein > 50 ng/ml

• Pregnancy, breast-feeding

• Other significant medical illness that might interfere with this study:

significant pulmonary dysfunction in previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)

• Substance abuse, such as alcohol (≥80 g/day), I.V. drugs and inhaled drugs in past 2 years. Current methadone usage is allowed.

• Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the study