CLINICAL TRIAL WITH TENOFOVIR VERSUS LAMIVUDINE PLUS ADEFOVIR DIPIVOXIL IN LAMIVUDINE-RESISTANT CHRONIC HEPATITIS-B PATIENTS WITH UNDETECTABLE VIRAL LOAD
- Conditions
- Therapeutic area: Diseases [C] - Virus Diseases [C02]MedDRA version: 14.0Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsCHRONIC HEPATITIS B
- Registration Number
- EUCTR2011-000629-55-ES
- Lead Sponsor
- Manuel Rodríguez García
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
? 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
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method