Evaluation of the efficacy of an antibiotic combined with standard treatment in severe alcoholic hepatitis

Phase 1

• Conditions: K70.1 (Severe Alcoholic hepatisis); MedDRA version: 19.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-002536-13-BE
• Lead Sponsor: Centre Hospitalier Régional et Universitaire de Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-16
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

- Patients aged 18-75
- Recent onset of jaundice (<3 months)
- Biopsy proven alcoholic hepatitis (transjugular liver biopsy)
- Maddrey’s discriminant function above 32, defining severe alcoholic hepatitis
- MELD score =21
- Alcohol consumption of more than 40g/day (women) and 50g/day (men)
- Written informed consent

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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Previous severe allergy or hypersensitivity to amoxicillin or clavulanic acid (anaphylactic shock, Quincke edema, severe urticaria)
- Hypersensitivity to any component of the medication
- History of liver injury to amoxicillin and/or clavulanic acid
- Phenylketonuria, because of the presence of aspartame in the powder for the oral suspension
- Type 1 hepatorenal syndrome before the initiation of treatment
- Severe extrahepatic disease
- Any malignant tumor < 2 years
- Uncontrolled gastrointestinal bleeding
- Ongoing viral or parasitic infection
- Untreated bacterial infection.
- Withdrawal from any antibiotic treatment less than 7 days. Patients who are currently being treated or were previously treated with antibiotics* for diagnosed infection or after a positive screening for infection may be included after wash-out period of 7 days (time from withdrawal of antibiotics to randomization).
- Tuberculosis < 5 years
- Positive blood PCR in patients with positive antibodies against HCV
- Patient carrying HBV or HIV
- Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study
-pregnant/nursing woman
*use of beta-lactams is preferred, when considering a low accumulation in the body

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified