Recruiting

Tenofovir Alafenamide with Fine Needle Aspiration Biopsy

Sponsor:

University Health Network, Toronto

Code:

NCT04070079

Conditions

Hepatitis B, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tenofovir Alafenamide

Study Details

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 analogue, Tenofovir alafenamide (TAF).

Conditions

Hepatitis B, Chronic

Study ID

NCT04070079

Start date

Jan 29, 2019

Status verified date

Aug, 2019

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Aug 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Tenofovir Alafenamide

Tenofovir Alafenamide 25mg, Dosed orally, once daily with or without food.

Interventions

Tenofovir Alafenamide

TAF 25mg once daily orally, for 48 weeks

Primary outcome measure

  • TAF-mediated reduction of inflammatory gene expression in intraheaptic immune cells [ Time Frame: 3 years ]
  • TAF-mediated reduction of serological markers of HBV replication [ Time Frame: 3 years ]
  • TAF-mediated reduction of intrahepatic HBV replication intermediates and cccDNA levels [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M3G 2C4

Contacts

Pujitha Rao

4163404800pujitha.rao@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 28, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2019-08-28.