E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alcoholic hepatitis |
Alkoholimaksatulehdus (alkoholihepatiitti) |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammation of liver caused by alcohol |
Alkoholimaksatulehdus |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 |
To evaluate the effect of ciprofloxacin therapy in adittion to prednisolone therapy to mortality in severe alcoholic hepatitis |
Prednisoloninhoitoon yhdistetyn siprofloksasiinin vaikutus vaikean alkoholihepatiitin kuolleisuuteen |
|
E.2.2 | Secondary objectives of the trial |
Effects of ciiprofloxacin to prognostic scores in severe alocohlic hepatitis |
Siprofloksasiinihoidon vaikutus vaikean alkolihepatiitin ennusteindekseihin |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Hospitalised patients with evere alcoholic hepatitis defined by modified Maddrey score over 300, patients over 18 |
Sairaalahoitoinen vaikea alkoholihepatiitti (modifioitu Maddreyn indeksi yli 300), yli 18-vuotiaita |
|
E.4 | Principal exclusion criteria |
- viral hepatitis B or C
- significant gastrointestinal bleeding (melaena) in past 4 days
- severe untreated bacterial infection
- severe renal failure (serum creatinine over 150 umol/l)
- patients previously enrolled to this study
- any other liver disease significantly affecting the course of alcoholic hepatitis (e.g. autoimmune hepatitis, untreated haemochromatosis)
- any malignancy not in remission
- patient unable to give informed consent |
- Virushepatiitit (tiedossa oleva B- tai C-hepatiitin kantajuus tai uutena todettu B- tai C-hepatiitti)
- Merkittävä ruuansulatuskanavan verenvuoto (melena) alle 4 vrk
- vaikea kontrolloimaton bakteeri-infektio
- merkittävä munuaisten vajaatoiminta, hepatorenaalinen syndroma, jossa S-kreat >150umol/l
- Kerran aiemmin tähän samaan tutkimukseen rekrytoitu alkoholihepatiittia sairastava henkilö.
- Jokin muu maksasairaus, jonka voidaan merkittävästi arvioida vaikuttavan alkoholihepatiitin taudinkulkuun (esimerkiksi ei remissiossa oleva autoimmuunihepatiitti tai hoitamaton hemokromatoosi).
- Ei-remissiossa oleva pahanlaatuinen sairaus.
- Potilas ei henkisen suorituskykynsä perusteella kykene sitoutumaan tutkimukseen.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mortality at day 28, at 3 months, 6 months and 12 months |
Kuolleisuus 28 päivän, 3 kuukauden, 6kuukauden ja 12 kuukauden kohdalla |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
day 28, 3 months, 6 months |
päivä 28, 3 kuukautta, 6 kuukautta |
|
E.5.2 | Secondary end point(s) |
- Proportion of patients with early change in bilirubin levels (ECBL= S-Bil(Day 0)-S-Bil(Day7 )>0
- Proportion of patients with Lille Score >0.45 day 7
- Recovery of liver function parameters in 1 and 3 months
|
- Biluriibinitason lasku 7 päivän kohdalla
- Lille score 7 päivän kohdalla
- Maksafunktioparametrien korjaantuminen 1 ja 3 kuukauden kohdalla |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
day 7 and 28, 3 months |
päivät 7 ja 28, 3 kuukautta |
|
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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 10 |
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 | No |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |