Innate immune responses in patients with chronic hepatitis B treated with Sebivo (telbivudine) - ND

Conditions: Chronic HBV
MedDRA version: 9.1Level: LLTClassification code 10008910

Registration Number: EUCTR2010-022627-29-IT

Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures