E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PROFILASSI PER RECIDIVA INFEZIONE HBV IN PAZIENTI TRAPIANTATI EPATICI |
|
MedDRA Classification |
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 |
lefficacia della somministrazione di HBIG IM a dosaggio decrescente (step down) nel mantenere titoli anticorpali efficaci |
|
E.2.2 | Secondary objectives of the trial |
- il dosaggio necessario al mantenimento del titolo anti-HBs target ≥ 300 U.I./L nel lungo termine (12 mesi) - le variabili influenti sul dosaggio di HBIG - i costi associati al trattamento - la compliance e la qualita` di vita del paziente, - la tollerabilita` del regime terapeutico. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Pazienti sottoposti a trapianto ortotopico di fegato per malattia epatica correlata alla epatite da virus B (HBV) - Adulti (eta` > 18 anni) - Di entrambi i sessi - Sottoposti a trapianto da almeno 12 mesi - in profilassi stabile con HBIG a somministrazione endovenosa - che abbiano firmato consenso informato allarruolamento allo studio - negativita` all HBV DNA determinata con analisi genomica (PCR per HBV DNA, viremia < 102 copie/ml) - con titolo anti-HBs &#8805; 300 U.I./L allarruolamento |
|
E.4 | Principal exclusion criteria |
Recidiva di epatite da virus B - Confezione con virus C (HCV) o HIV - Reinfezione da virus B (HBV DNA > 102 copie/ml) - Documentata incapacita` al mantenimento di un titolo anti HBs stabile in immunoprofilassi con HBIG (almeno 2 evidenze di titolo pre-somministrazione < 100 U.I./L nellanno precedente) - Ipersensibilita` o storia di manifestazioni allergiche a derivati del plasma - Disturbi della coagulazione: piastrinopenia (plts< 50.000/µl), coagulopatie acquisite o congenite |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Lend point principale dello studio e` il mantenimento del titolo protettivo anti-HBs e la possibilita` di riduzione del dosaggio rispetto al regime precedentemente attuato (espresso in U.I./mese) ed al protocollo di trattamento allarruolamento |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
controllo intragruppo storico |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |