E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10019805 |
E.1.2 | Term | Hepatobiliary disorders |
|
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 |
Efficacy of TDF 300 mg monotherapy, in unselected, NUC naive or IFN experienced patients with chronic hepatitis B referring to outpatient liver clinic. |
|
E.2.2 | Secondary objectives of the trial |
The biochemical and serological response and the safety profile of TDF given for 48 weeks in unselected HBV monoinfected patients; The impact of therapy on liver related complications; The emergence of viral resistance. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
 > 18 years of age  Chronic HBV infection, defined as positive serum HBsAg for at least 6 months  Serum HBV DNA  105 copies/mL for HBeAg+ve (>2000 U/ml)  Serum HBV DNA  104 copies/mL for anti-HBe+ve (>2000 U/ml)  Serum ALT  20  ULN  Hemoglobin  8 g/dL  Neutrophils  750 /mm3  Subjects NUC naive or IFN experienced.  Patients with compensated liver disease as well as patients with concomitant diseases or medications  Willing and able to provide written informed consent |
|
E.4 | Principal exclusion criteria |
Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study Male or females of reproductive potential who are unwilling to put into action all necessary steps to avoid pregnancy while enrolled in the study Co-infection with HCV (based on serology), HIV, or HDV Significant renal (CrCl<50 mL/min), cardiovascular, pulmonary, or neurological disease Patients with evidence of HCC with appropriate screening procedures (&#945; fetoprotein and liver US) Currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, agents capable of modifying renal excretion Proximal tubulopathy Known hypersensitivity to the study drug (tenofovir DF) or formulation excipients |
|
E.5 End points |
E.5.1 | Primary end point(s) |
HBV DNA levels: < 400 copies/ml at wk 48 |
|
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
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
| |
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 |