Prevention of re-onset of HBV infection in patients apparently cured affected by rheumatological diseases requiring finite duration treatments with drugs that impair the immune systems.

Prophylaxis of Hepatitis B reactivation in patients with HBV occult infection and rheumatological diseases candidates to immune suppressive treatments of finite duration. - Prophylaxis of OBI reactivation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000570-35-IT

Enrollment

Registered

2021-01-26

Start date

2016-02-10

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occult Hepatitis B virus Infection (OBI) in patients with rheumatologic diseases candidate to treatment a finite duration (less than 18 months) with potent immune suppressive drugs MedDRA version: 20.0 Level: HLT Classification code 10037163 Term: Psoriatic arthropathies System Organ Class: 100000004859 MedDRA version: 20.1 Level: HLT Classification code 10057212 Term: Hepatitis viral infections System Organ Class: 100000004862 MedDRA version: 20.0 Level: HLT Classification code 10039075 Term

Interventions

Trade Name: VIREAD - 245 MG 30 COMPRESSE RIVESTITE CON FILM IN FLACONE USO ORALE Product Name: VIREAD 30 CPR 245 MG Product Code: 35565011 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age > 18 years; - Patient affected by rheumatois arthrits and psoriasic arthrits, non responders to DMARDs (AR) or FANS/DMARDs (AP), candidates to immunesuppressive treatment with etanercept or adalimubab (finite therapy of 18 months) - Written informed consent - HBsAg negativity, anti-HBc positivity (with/without anti-HBs) - HBV-DNA negativity (by Polymerase Chain Reaction) - Normal liver tests (AST ed ALT 80 ml/min, serum phospate > 2 mg/dl) - No previous treatment with HBV drugs - Adoption of adequate contraceptive measures in childbearing wowen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: - Age 1,5 max normal values; PCHE, serum Albumin and Total Bilirubin levels outside normal range) - anti-HIV positivity - anti-HCV positivity - Latent Tubercolosis infection - Controindications to Tenofovir - Abnormal kidney function ( creatinine clearance < 80 ml/min, serum phosphate < 2 mg/dl) - Previous treatment with HBV drugs - Refusal of adoption of adequate contraceptive measures in childbearing wowen - Pregnancy - Breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To prevent by prophlactic administration of tenofovir the risk of reactivation of HBV (namely the reappearance of serum markers of viral replication such as HBsAg and HBV DNA), that can lead to serious and often fatal outcomes, in a subject previously tested to be HBsAg negative, anti-HBc positive, HBV DNA negative (OBI) affected by prevention in a setting of patients with OBI affected by rheumatological disease,who are candidate to treatment of finite duration (less than 18 months) with potent immune suppressive drugs, followed by UOC di Malattie Virali incluso AIDS DH and UOC Reumatologia of AOU ¿Federico II¿ of Napoli" ;Secondary Objective: - Evaluate the rate of patients with OBI who reactivate HBV during the immune suppressive therapy -Evaluate the rate of patients with OBI who reactivate HBV within 12month after end of immune suppressive therapy. - Evaluate the rate of patients who withdraw protocol treatment because of HBV reactivation - To prevent the severe ALT flares due to HBV reactivation, that cause premature discontinuation of immunesuppressive treatment and worsening of the rheumatological disease - To compare the prophylaxis with tenofovir to the early therapy with antiviral drug soon after the onset of reactivation of hepatitis B . -To prevent the risk of chronicity that is higher in this setting of patients respect to immune competent patients - To charge the patient with HBV reactivation;Primary end point(s): Percentage of patients with serum HBVDNA levels below 20 UI/L (PCR negative) and HBsAg- negativity at the end of the study;Timepoint(s) of evaluation of this end point: 30 months (namely 12 months after the withdrawal of immune suppressive therapy)	—

Measure

Time frame

Main Objective: To prevent by prophlactic administration of tenofovir the risk of reactivation of HBV (namely the reappearance of serum markers of viral replication such as HBsAg and HBV DNA), that can lead to serious and often fatal outcomes, in a subject previously tested to be HBsAg negative, anti-HBc positive, HBV DNA negative (OBI) affected by prevention in a setting of patients with OBI affected by rheumatological disease,who are candidate to treatment of finite duration (less than 18 months) with potent immune suppressive drugs, followed by UOC di Malattie Virali incluso AIDS DH and UOC Reumatologia of AOU ¿Federico II¿ of Napoli" ;Secondary Objective: - Evaluate the rate of patients with OBI who reactivate HBV during the immune suppressive therapy -Evaluate the rate of patients with OBI who reactivate HBV within 12month after end of immune suppressive therapy. - Evaluate the rate of patients who withdraw protocol treatment because of HBV reactivation - To prevent the severe ALT flares due to HBV reactivation, that cause premature discontinuation of immunesuppressive treatment and worsening of the rheumatological disease - To compare the prophylaxis with tenofovir to the early therapy with antiviral drug soon after the onset of reactivation of hepatitis B . -To prevent the risk of chronicity that is higher in this setting of patients respect to immune competent patients - To charge the patient with HBV reactivation;Primary end point(s): Percentage of patients with serum HBVDNA levels below 20 UI/L (PCR negative) and HBsAg- negativity at the end of the study;Timepoint(s) of evaluation of this end point: 30 months (namely 12 months after the withdrawal of immune suppressive therapy)

—

Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients with normal AST and ALT levels (serum aminotransferase) 80 ml/min) at the end of the study; Percentage of patients with serum phophaste levels in the normal range (>2 mg/dl) at the end of the study; Percentage of patients with at least a 6% decrease from baseline in bone mineral density at the end of the study; Percentage of patients who withdraw immune suppressive therapy because of events related to HBV reactivation; Percentage of patients in whom HBV reactivation progress to chronicity; Percentage of patients charged by UOC Malattie Virali incluso AIDS DH because of HBV-related events;Timepoint(s) of evaluation of this end point: 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive	—

Measure

Time frame

Secondary end point(s): Percentage of patients with normal AST and ALT levels (serum aminotransferase) 80 ml/min) at the end of the study; Percentage of patients with serum phophaste levels in the normal range (>2 mg/dl) at the end of the study; Percentage of patients with at least a 6% decrease from baseline in bone mineral density at the end of the study; Percentage of patients who withdraw immune suppressive therapy because of events related to HBV reactivation; Percentage of patients in whom HBV reactivation progress to chronicity; Percentage of patients charged by UOC Malattie Virali incluso AIDS DH because of HBV-related events;Timepoint(s) of evaluation of this end point: 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive therapy); 30 months (namely 12 months after the withdrawal of immune suppressive

—

Countries

Italy

Contacts

Public ContactU.O.C. DI MALATTIE VIRALI INCLUSO A

AOU FEDERICO II NAPOLI

grazia.tosone@unina.it0817463082

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026