Double blind, randomized, clinical trial to evaluate efficacy and safety of Phyllanthus amarus versus placebo in the treatment of patients with chronic hepatitis B - CORONA

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA0 个研究点开始时间: 2008年7月14日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Males and females 18-75 years of age
•Proven CHB defined as follows:
•oSerum HBsAg positivity at the screening visit and at least in another occasion in the previous six months;
•oSerum liver enzymes elevation documented in at least two occasions within the previous six months;
•oAlanine aminotransferase (ALT) level 1.3 to 10 fold upper limit of normal range and serum HBVDNA ≥ 4Log cp/mL at the screening visit;
•oEvidence of chronic liver disease consistent with CHB on a biopsy obtained within the previous 36 months
•Willingness to give written informed consent and willingness to participate and comply with the study
•Willingness to avoid conceptions during the study
•Absence of indication for approved treatment for CHB (interferons, lamivudine or adefovir) or previous documented intolerance to one of these treatments.
•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) no
•F.1.3.1 Number of subjects for this age range

•Documented ipersensibility to the study treatment or to one of its excipients
•Co-infection with HCV, HDV or HIV
•Ongoing treatment with corticosteroids or immunodepressant drugs
•History or other evidence of bleeding from esophageal varices or other conditions consitent with decompensated liver disease
•History of malignancy in the previous 5 years
•Data suggesting hepatocarcinoma (HCC)
•One of the following biochemical features at the screening visit:
•oHemoglobin (Hb) <11g/dL in males and <10g/dL in females
•oWhite blood cells<3500/mm3; absolute neutrophil count<1500/mm3
•oPlatelets count<75000/mm3; serum amylases or lipases >1.5*ULN
•oSerum albumin<3.3g/dL; total bilirubin≥2mg/dL; ANA>1:320
•oCreatinine Clearance<50 mil/min
•oAlphafetoprotein (AFP) >50ng/mL
•Pregnancy or breast feeding

发起方

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA