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

• Conditions: Chronic hepatitis B; MedDRA version: 9.1Level: PTClassification code 10019731Term: Hepatitis B

• Registration Number: EUCTR2008-000257-36-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main aim of the study is to investigate efficacy of a twelve months course of Phyllantus amarus on the clearance of serum HBVDNA, tested with Versant HBVDNA, in patients with CHB not suitable for standard therapies.;Secondary Objective: The principle secondary objectives of the study are:<br>&#61607;To test level of serum HBVDNA at months 1, 3, 6, 9 ,12, and 18 to evaluate how study treatment may affect viral kinetics;<br>&#61607;To evaluate rate of HBsAg and HBeAg (in patients HBeAg+) seroconversion at months 1, 3, 6, 9, 12 and 18;<br>&#61607;To evaluate the rate of serum liver enzymes normalization during treatment;<br>To evaluate the rate of persistent serum HBVDNA clearance and serum liver enzymes normalization 6 months after the end of treatment.;Primary end point(s): Determination of sieric HBVDNAwith Versant HBV TM method (detectable level 2000 cpoies/ml), wich is the standard evaluation in clinical studies on chronic Hepatitis B virus