Status:
UNKNOWN
Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:
Lead Sponsor:
University Health Network, Toronto
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 analo...
Detailed Description
Investigator-initiated, phase 4 study in which recruited patients will receive, TAF 25mg once daily, for 48 weeks (Figure 1 and Table 1). The total duration of the study to End of Follow-up (EOF) will...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04070079
Start Date
January 29 2019
End Date
December 31 2022
Last Update
August 28 2019
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M3G 2C4