Treatment with association of two drugs (Viread and Pegasys) in patients with hepatitis B.

Phase 1

Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]
Hepatitis B virus (HBV)

Registration Number: EUCTR2014-000453-37-IT

Lead Sponsor: Azienda Ospedaliera di Padova

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

Inclusion Criteria

- Patients with chronic hepatitis HBsAg positive, HBeAg negative HBV-DNA> 20,000 IU / mL in two successive determinations or chronic hepatitis HBsAg positive, HBeAg positive with HBV DNA> 20,000 IU / mL in two successive determinations;
- for which the practitioner indicates a treatment with peg-interferon alfa-2a;
- with transaminases > 2 times the normal range in two successive determinations;
- anti-HDV, anti-HCV and anti-HIV negative;
- of which there is liver biopsy performed within 24 months prior to the start of therapy or Fibroscan performed within 6 months, proving HBV-related chronic hepatitis;
- observing absolute abstention from alcohol;
- available to participate in the study (informed consensus).
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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Concomitant conditions that, in the opinion of the investigator, could compromise the patient's participation in the study or the results of the study, causing interference on the assessments provided by this protocol;
- patients that are pregnant or breastfeeding;
- people who are unable to understand and decide;
- refusal to participation/withdrawal of consensus;
- Hb <10 g/dl;
- neutrophil count <1,500 cells/ml;
- platelets <90,000 cells/ml;
- treatment with antiviral therapy during the 12 months preceding the visit of enrollment in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effectiveness resulting from the addition of a treatment with Tenofovir before the start of therapy with peg-IFN-2a compared to treatment with peg-IFN-2a on the biochemical, virological and serological response in patients with chronic hepatitis HBeAg negative/positive .;Secondary Objective: Not applicable;Primary end point(s): Rate of sustained virological response (HBV DNA levels <2000UI/mL);Timepoint(s) of evaluation of this end point: 6 months from the end of treatment with peg-interferon alfa-2a

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Rate of biochemical response (normalization of ALT: <40 U / L);Timepoint(s) of evaluation of this end point: 6-12 months from the end of treatment with peg-interferon alfa-2a