chronic hepatitis B MedDRA version: 9.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tenofovir disoproxil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Sponsors
OSPEDALE MAGGIORE DI MILANO (IRCCS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  > 18 years of age  Chronic HBV infection, defined as positive serum HBsAg for at least 6 months  Serum HBV DNA  105 copies/mL for HBeAg+ve (>2000 U/ml)  Serum HBV DNA  104 copies/mL for anti-HBe+ve (>2000 U/ml)  Serum ALT  20  ULN  Hemoglobin  8 g/dL  Neutrophils  750 /mm3  Subjects NUC naive or IFN experienced.  Patients with compensated liver disease as well as patients with concomitant diseases or medications  Willing and able to provide written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study Male or females of reproductive potential who are unwilling to put into action all necessary steps to avoid pregnancy while enrolled in the study Co-infection with HCV (based on serology), HIV, or HDV Significant renal (CrCl<50 mL/min), cardiovascular, pulmonary, or neurological disease Patients with evidence of HCC with appropriate screening procedures (&#945; fetoprotein and liver US) Currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, agents capable of modifying renal excretion Proximal tubulopathy Known hypersensitivity to the study drug (tenofovir DF) or formulation excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of TDF 300 mg monotherapy, in unselected, NUC naive or IFN experienced patients with chronic hepatitis B referring to outpatient liver clinic.;Secondary Objective: The biochemical and serological response and the safety profile of TDF given for 48 weeks in unselected HBV monoinfected patients; The impact of therapy on liver related complications; The emergence of viral resistance.;Primary end point(s): HBV DNA levels: < 400 copies/ml at wk 48 | — |
Countries
Italy
Outcome results
None listed