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

NCT ID: NCT04070079

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2022-12-31

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).

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 be 48 weeks. After Week 48, participants will be offered 2 years of TAF therapy. Sample collection 0, 12, 24 w was chosen to analyze immune responses based on ALT normalization rates. This mono-center study will be conducted at Toronto Centre for Liver Disease, Canada.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenofovir Alafenamide

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

Group Type: OTHER

Tenofovir Alafenamide

Intervention Type: DRUG

TAF 25mg once daily orally, for 48 weeks

Interventions

Tenofovir Alafenamide

TAF 25mg once daily orally, for 48 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Harry Janssen

Chief of Hepatology | Director Toronto Centre for Liver Disease | Director Viral Hepatitis Care Network (VIRCAN) | Professor of Medicine, University of Toronto |

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Pujitha Rao

Role: primary

pujitha.rao@uhn.ca

4163404800 ext. 6651

Other Identifiers

CO-US-320-4667

Identifier Type: -

Identifier Source: org_study_id