Use of TDF in Patients With Inactive Chronic Hepatitis B Infection

NCT02600117 | Completed Phase 3

• 2 other identifiers: 15-8950IN-CA-174-1708
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Recent evidence suggests that patients with inactive chronic hepatitis B (CHB) may develop the same types of liver complications that patients in the active state of hepatitis B virus (HBV) infection experience. Treatment guidelines for patients in the active state of HBV infection indicate that HBsAg clearance is associated with definitive remission of the activity of chronic HBV \& improved long-term outcome. Clinical data showed that HBsAg clearance is achievable, in a small population of patients on continuous treatment with potent oral antivirals (OAVs), such as tenofovir disoproxil fumarate (TDF). It is possible the same OAVs can have the same effect in patients with inactive CHB, but in a shorter treatment duration. The purpose of this study is to find out if TDF is effective in controlling HBV DNA \& promoting seroconversion from HBsAg-positive to HBsAb-positive in patients with inactive CHB.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Seroconversion from hepatitis B surface antigen positive to hepatitis B surface antibody positive

  Positive hepatitis B surface antibody result will indicate recovery from chronic hepatitis B virus infection.

  Three years

Study Arms (1)

Tenofovir disoproxil fumarate

OTHER

300 mg, orally, once a day for 3 years or when sAg+ve seroconverts to sAb+ve whichever comes earlier

Drug: Tenofovir disoproxil fumarate

Interventions

Tenofovir disoproxil fumarate DRUG

300 mg, oral, once a day

Also known as: Viread

Tenofovir disoproxil fumarate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with inactive chronic hepatitis B, defined as someone who has HBV DNA ≤ log4, eAg-ve, eAb+, HBsAg+ve and normal ALT persistently for \>6 months

You may not qualify if:

• Patients older than 75 years of age
• Presence of hepatoma at entry
• Presence of decompensated cirrhosis defined by a history of variceal bleed, ascites, or hepatic encephalopathy
• Presence of abnormal renal function defined as serum creatinine of\>110µmol/L
• co-infection with HIV

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Gilead Sciences: collaborator

Study Sites (1)

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Florence Wong, MD

  University Health Network -Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Hepatologist, Professor-Division of Gastroenterology,Department of Medicine, University of Toronto

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 9, 2015
• Study Start: January 26, 2016
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

CA (1)