E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019731 |
E.1.2 | Term | Hepatitis B |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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) <11g/dL in males and <10g/dL in females o White blood cells<3500/mm3; absolute neutrophil count<1500/mm3 o Platelets count<75000/mm3; serum amylases or lipases >1.5*ULN o Serum albumin<3.3g/dL; total bilirubin≥2mg/dL; ANA>1:320 o Creatinine Clearance<50 mil/min o Alphafetoprotein (AFP) >50ng/mL  Pregnancy or breast feeding |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Ritiro consenso; Aggravamento quadro clinico tale da giustificare inizio terapia anti-virale. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |