Efficacy and tolerance of alpha tocopherol hydrogen succinate in paediatric patients with HBsAg positive chronic hepatitis
| DEC-NET Serial number IT405 | |
| Published online | 24/05/2005 10.32.00 |
| Last updated | 25/05/2005 15.25.47 |
| Other protocol ID number | |
| Current trial status | Planned (i.e. not yet recruiting participants) |
| Major Disease (ICD9 class) | CHRONIC VIRAL HEPATITIS B WITHOUT HEPATIC COMA WIT |
| Experimental drug | |
| DL-alpha tocopherol hydrogen succinate | |
| Gender | Both |
| Age (range) | 2-17 years |
Eligibility criteria | |
| Inclusion criteria | |
| - not pregnant and use of contraceptive from at least 4 weeks prior to treatment and until 30 days afterwards (for women of childbearing age) - parents or carers who are able to give an informed, written consent and follow the study procedures - serum positivity for HBsAg for at least 6 months prior to randomisation - Informed consent by parents/legal carer of patient - ... | |
| Exclusion criteria | |
| - Any serious, concomittant clinical or psychiatric condition that may influence the treatment, clinical evaluations, or adherence to the protocol - hepatic disease due to other causes - treatment with steroids or immuno-suppressive or chemiotherapic agents in the two months prior to the screening - alcoho/drug abuse - pregnancy or breastfeeding - ... | |
Trial design/methodology | |
| Phase | 2 |
| Kind of study | Efficacy Safety |
| Design | Randomised |
| Purpose of study | |
| - To evaluate the efficacy and tollerability of vitamin E treatment in children with HBsAg/HBeAg positive chronic hepatitis - evaluate the tollerability of vitamin E administration - evaluate vitamin E.s efficacy in inducing HBV-DNA suppression and normalising transaminase levels. | |
| Principal investigator | |
| Name | Dott. S Fiorino |
| Institution | Medicina 2 Ospedale di Budrio Azienda USL Bologna Cittą |
| Postal address | Via Benni, 44 - 40054 |
| City | Bologna |
| Country | ITALY |
| Phone | 051 809111 |
| Fax | |
| sirio.fiorino@ausl.bo.it | |
| Participating centres |
| Dipartimento di Medicina Interna, CardioAngiologia, Epatologia. Universitą di Bologna (Bologna) |
| Dipartimento di Medicina Clinica Specialistica e Sperimentale Sezione Malattie Infettive, Universitą degli Studi di Bologna (Bologna) |
| U.O. Malattie Infettive, IRCCS Gaslini (Genova) |
| Reparto di Medicina 5° Dipartimento di Medicina Clinica Specialistica e Sperimentale, Azienda Ospedaliera - Universitą degli Studi di Padova (Padova) |
| Dipartimento di Pediatria, Azienda Ospedaliera - Universitą degli Studi di Padova (Padova) |
| U.O. Complessa di Epatologia - Ospedale Pediatrico Bambin Gesł IRCCS di Roma (Roma) |
| Dipartimento di Scienze Pediatriche e Adolescenza - 3° Divisione Pediatria Generale e Gastroenterologia. Ospedale Regina Margherita di Torino (Torino) |
| Unitą Ospedaliera di Pediatria, Azienda Mista Ospedaliero-Universitaria Anna Meyer di Firenze (Firenze) |
| ISRCTN | EudraCT |
