Sequential treatment with nucleotide analogue and peg-interferon in patients with HBV-related chronic hepatitis. - TRASANPIEC-HBV

Azienda Ospedaliera di Padova0 个研究点目标入组 80 人开始时间: 2014年9月3日最近更新: 2018年2月26日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Azienda Ospedaliera di Padova