Chronic hepatitis B MedDRA version: 9.1 Level: PT Classification code 10019731 Term: Hepatitis B
Conditions
Interventions
Product Name: dabur 007 phyllanthus
Product Code: E 06 25494-Y
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Males and females 18-75 years of age  Proven CHB defined as follows: o Serum HBsAg positivity at the screening visit and at least in another occasion in the previous six months; o Serum liver enzymes elevation documented in at least two occasions within the previous six months; o Alanine aminotransferase (ALT) level 1.3 to 10 fold upper limit of normal range and serum HBVDNA ≥ 4Log cp/mL at the screening visit; o Evidence 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
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: o Hemoglobin (Hb) 1.5*ULN o Serum albumin1:320 o Creatinine Clearance50ng/mL  Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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:  To test level of serum HBVDNA at months 1, 3, 6, 9 ,12, and 18 to evaluate how study treatment may affect viral kinetics;  To evaluate rate of HBsAg and HBeAg (in patients HBeAg+) seroconversion at months 1, 3, 6, 9, 12 and 18;  To evaluate the rate of serum liver enzymes normalization during treatment; 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 | — |
Countries
Italy
Outcome results
None listed