Chronic HBV MedDRA version: 9.1 Level: LLT Classification code 10008910
Conditions
Interventions
Trade Name: SEBIVO*28CPR RIV 600MG
Pharmaceutical Form: Coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical Form: Film-coated tablet
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-70 years, serum HBsAg positivity for at least 6 months, na?vete` to (Peg)-interferons and nucleoside/nucleotide analogs, HBV-DNA levels = 7 Log10 copies/mL (HBeAg-negative patients) or = 9 Log10 copies/mL (HBeAg-positive patients). 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: Coinfection with HIV, HCV, HDV, evidence of hepatic decompensation or hepatocellular carcinoma, major comorbidities, alcohol or drug abuse, Pregnant or breastfeeding patients. Women of childbearing potential must have a negative serum betahuman chorionic gonadotropin (ß-HCG) during screening and use any combination of hormonal contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if treatment with Sebivo (telbivudine) plays a role in native immune responses in patients affected by chronic hepatitis B: - to determine whether treatment with telbivudine can restore cytokine production by natural killer cells (NK) - to determine whether the same antiviral treatment can influence NK;Secondary Objective: To evaluate the virological, biochemical and serological efficacy of Sebivo (telbivudine) in patients affected by chronic hepatitis B;Primary end point(s): See "main objective" | — |
Countries
Italy
Outcome results
None listed