Chronic Hepatitis B HBV MedDRA version: 14.1 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: TENOFOVIR DSOPROXIL FUMARATE
Concentration unit: mg milligram(s)
Concentration number: 245-
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
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 ? Active chronic HBV infection with all the following:  Currently treated with adefovir dipivoxil 10 mg QD or the combination of adefovir dipivoxil 10 mg QD and lamivudine 100 mg QD (for  48 weeks)  HBeAg+ve or anti-HBe+ve at screening  Serum HBV DNA  104 copies/mL  Serum ALT  20  ULN  Hemoglobin  8 g/dL  Neutrophils  750 /mm3 ? Adefovir or lamivudine-experienced ? Negative serum -HCG ? Compliant with adefovir dipivoxil ? Willing and able to provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 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. ? Prior use of tenofovir DF or entecavir ? Received treatment with interferon or pegylated interferon within 6 months of the screening visit. ? Co-infection with HCV (based on serology), HIV, or HDV. ? Significant renal, cardiovascular, pulmonary, or neurological disease. ? Received solid organ or bone marrow transplantation. ? 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 drugs (tenofovir DF or emtricitabine/tenofovir DF), the metabolites (tenofovir or emtricitabine) or formulation excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? Val la capacita' di un trattamento prolungato con TDF (300 mg/die) +/- LAM (100 mg/die) di indurre la soppressione ottimale della replicazione di HBV (livelli HBV-DNA < 400 copie/ml) e controllo della malattia epatica (livelli ALT normali) nell'epatite cronica B HBeAg positiva e anti-HBe positiva con risposta sub-ottimale alla terapia ADV o ADV/LAM. ? Valutare la durabilita' della soppressione completa della replicazione HBV (livelli HBV-DNA < 400 copie/ml) e del controllo della malattia epatica (livelli ALT normali) indotti da TDF (300 mg/giorno) +/- LAM (100 mg/giorno) nell'epatite cronica B HBeAg positiva e anti-HBe positiva con risposta sub-ottimale alla terapia ADV o ADV/LAM. ? Valutare la capacita' di un trattamento prolungato con TDF (300 mg/giorno) +/- LAM (100 mg/giorno) di indurre perdita dell'HBeAg, siero-conversione anti-HBe e controllo della malattia epatica (livelli ALT normali) nell'epatite cronica B HBeAg positiva con risposta sub-ottimale alla terapia ADV o AD;Secondary Objective: ? To evaluate the capability of a prolonged treatment with TFD (300 mg/die) +/- LAM (100 mg/die) to induce optimal suppression of HBV replication (HBV-DNA levels < 400 copies/ml) and control of liver disease (normal ALT levels) in HBeAg +ve and anti-HBe +ve CHB with suboptimal response to ADV or ADV/LAM therapy ? To evaluate the durabity of the optimal suppression of HBV replication (HBV-DNA levels < 400 copies/ml) and control of liver disease (normal ALT levels) induced by TDF (300 mg/die) +/- LAM (100 mg/die) in HBeAg +ve and anti-HBe +ve CHB with suboptimal response to ADV or ADV/LAM therapy ? To evaluate the capability of a prolonged treatment with TFD (300 mg/die) +/- LAM (100 mg/die) to induce HBeAg loss and seroconversion.and control of liver disease (normal ALT levels) in HBeAg +ve CHB with suboptimal response to ADV or ADV/LAM therapy ? To evaluate the durabity of HBeAg loss and seroconversion.and control of liver disease (normal ALT levels) in | — |
Countries
Italy
Outcome results
None listed