CHRONIC HEPATITIS B MedDRA version: 14.0 Level: LLT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Manuel Rodríguez García
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male and female patients over 18 years of age ? HBsAg positive at the beginning of the trial (basal visit) ? Patients with LAM resistant Chronic Hepatitis B ? Patients with LAM and ADV treatment for at least the last 6 months prior to the beginning of the trial ? Patients with undetectable HBV-DNA. ? Patients with compensated liver disease 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 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: ? Intolerance to any treatment component. ? Co-infection with other viruses such as HCV, HDV or HIV. ? Identified viral mutations associated with resistance to ADF. ? Presence of hepatocellular carcinoma ? Patients with severe or moderate renal failur ? Liver or kidney transplant or severe renal, lung or neurological diseases that under investigator criteria may interfere in the patient?s participation during the clinical trial. ? Pregnancy or breastfeeding. ? Treatment within the last 30 days with any experimental (non-authorised) drug. ?Any other disease or condition that might render the patient ineligible for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To assess Non-inferiority of monotherapy with TENOFOVIR versus LAMIVUDINE plus ADEFOVIR DIPIVOXIL in lamovudine-resistant chronic hepatitis-B patients in undetectable viral load (DNA-HBV under lower limit of quantification) mainteinance;Secondary Objective: ? To estimate the number of patient (%) with undetectable viral load (DNA-VHB below the lower limit of quantification) at 12, 24 and 36 weeks of treatment ? To assess throughout the 48 weeks of the trial the incidence of resistance-mutations in patients with treatment failure (detection of viral replication). ? To estimate the number of patients (%) with AgHBe and AgHBs loss and seroreversion at 12, 24, 36 and 48 weeks. ? To assess the changes in AgHBs levels at 12, 24, 36 and 48 weeks ? To assess the treatment adherence ? To estimate the incremental cost between therapies ? To collect both clinical and laboratory adverse events;Primary end point(s): ? The percentage of patients with sustained virological response (undetectable HBV-DNA levels or HBV-DNA below the lower limit of quantification) after 48 weeks of treatment.;Timepoint(s) of evaluation of this end point: ? 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? The percentage of patients with sustained virological response (undetectable HBV-DNA levels or HBV-DNA below the lower limit of quantification) after 12, 24 and 36 weeks of treatment. ? Proportion of patients with treatment failure (detectable HBV-DNA levels or HBV-DNA level that exceeds the lower limit of quantification) in each treatment group. ? Virological response at 12, 24 and 36 weeks of treatment assessed as percentage of patients with HBeAg or HBsAg loss or seroreversion ? Variations in HBsAg levels after 12, 24, 36 and 48 weeks of treatment. ? Treatment?s adherence assessed with the Morisky-Green scale. ? Drug safety. Number of serious adverse events (clinical or laboratory abnormalities). ? Incremental cost between therapies by means of a cost-minimization analysis;Timepoint(s) of evaluation of this end point: ? after 12, 24 and 36 weeks of treatment. ? after 12, 24, 36 and 48 weeks of treatment. ? after 12, 24 and 36 weeks of treatment. ? after 12, 24, 36 and 48 weeks of treatment. ? after 48 weeks of treatment. ? after 48 weeks of treatment. | — |
Countries
Spain
Contacts
Public ContactPORIB
Pharmacoecomomics & Outcomes Research Iberia
Outcome results
None listed