EUCTR2016-005136-16-BEActive, not recruitingPhase 1
Corticosteroids in patients with severe alcoholic hepatitis patients in early spontaneous improvement - Cortisave
CUB Erasme Hospital0 sites140 target enrollmentStarted: April 21, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Male or female, 18 years of age or older at time of screening
- •2.Clinical syndrome of alcoholic hepatitis: recent jaudice or in recent aggravation (< 3 months) serum bilirubin > 5 mg/dL history of excess alcohol abuse (> 40g/day)
- •3. Alcoholic hepatitis proven by a liver biopsy (histological criteria of alcoholic hepatitis defined according to EASL clinical practice guidelines : steatosis, hepatocyte ballooning, and an inflammatory infiltrate with PMNs). The results are not mandatory for inclusion. However, the biopsy must be planned at the latest on Day 1. When the results become available and don’t confirm the alcoholic hepatitis, the patient must discontinue the study.
- •4. Spontaneous liver function improvement, defined by a decrease in serum bilirubin level > 10% between admission and day 5-10 after admission
- •5. less than 2 weeks since admission to hospital
- •6. Maddrey discriminant function* greater than or equal to 32
- •7. Subjects must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study-specific procedures.
- •8. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
- •Patients with significant hepatic encephalopathy are not excluded from participation to the trial. In this case, the patient should be accompanied by a legal representative that will decide participation in the clinical study and sign ICF.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
Exclusion Criteria
- •1. Other causes of liver disease including viral hepatitis (positive HBs antigen, HCV RNA positive), auto-immune hepatitis, biliary obstruction
- •2. Other disease compromising 90-day survival
- •3. Positive HIV serology
- •4. Uncontrolled infection
- •All patients will be screened for infection. This will involve chest radiography, urinalysis, PMNs count in ascites (if ascites present). All other sign or clinical suspicion of infection with or without antibiotherapy will be recorded as an infection.
- •Positive culture and initiation of antibiotics with clinical or radiological signs of infection, as well as clinical suspicion, will be recorded as infection.
- •Patients with evidence of sepsis will be treated for a minimum of 2 days with appropriate antibiotics. Once the local principal investigator considers that the sepsis is under control, the patient may be rescreened and randomised.
- •5. Uncontrolled gastrointestinal bleeding
- •Bleeding must be judged as controlled for at least 5 days
- •6. Patient with serum creatinine > 2.5 mg/dL, under renal replacement therapy or under terlipressine (or other vasoactive drugs)
- •7. Pentoxyphilline therapy
- •8. Pregnant or lactating women
Investigators
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