ClinicalTrials.gg
Sign In
Status unknownNCT02116556RIFA-AAHUpdated Nov 4, 2016

Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

A Phase 2 interventional study of Prednisone and Rifaximin in Alcoholic Hepatitis, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 4 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-11-04.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis.

The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.

Read the detailed description

Design: Open multicenter comparative study. A cohort (n = 66) will receive rifaximin (1200 mg / d) for 90 days. Results will be compared with those of a cohort of AAH prospectively included in an observational study. Both groups with a uniform treatment protocol (which includes the administration of corticosteroids and standardized treatment for complications of liver failure). Patients will be monitorized until hospital discharge and a follow-up visit at 7, 30, 45, 60 and 90 days will be performed.

Endpoints:

  1. Primary endpoint: Bacterial infections after 90 days.
  2. Secondary endpoints: :

2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival

02

Conditions studied

  • Alcoholic Hepatitis

Keywords

  • Alcoholic Hepatitis
  • Bacterial Infections
  • Acute-on-Chronic Liver Failure
03

In context

Hepatitis, Alcoholic

108 studies on the registry are indexed under Hepatitis, Alcoholic; 23 are open to participants now.

This study's enrollment of 29 is below the median of 60 across 76 interventional studies indexed under Hepatitis, Alcoholic.

Browse Hepatitis, Alcoholic studies →

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 275 studies on the registry; 63 are open to participants now.

Browse Hospital Universitari Vall d'Hebron Research Institute studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients ≥18 and \<70 years of age.
  • Active alcohol abuse and excessive alcohol consumption prior to admission defined as > 50 g per day for men and> 40 g per day for women.
  • Jaundice (Bilirubin >2 mg/dl) for no more than 3 months.
  • Clinical suspicion of Alcoholic Hepatitis with a modified Maddrey's Discriminant Function > 32 points.

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity to Rifaximin
  • Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: all conditions evolved into a clinical stage to limit the patient's functional status (eg, heart failure NYHA> II, COPD PCO2> 50 mmHg or PO2 \<60 mmHg, stroke or other disabling neurological disease, disabling or uncontrolled oncological conditions, etc ...).

Terminal illness will be defined as any clinical conditions with a survival expectancy less than 3 months

  • Hepatocellular carcinoma (previously diagnosed) beyond Milan's criteria.
  • Complete portal vein thrombosis (previously diagnosed).
  • Autoimmune liver disease.
  • Hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV positive).
  • Pregnancy or nursing.
  • Use of Rifaximin during the previous 2 months.
  • Treatment with Pentoxifylline.
  • Lack of informed consent.

Removal criteria:

  • Lack of histological confirmation of Alcoholic Hepatitis during the first 7 days after inclusion.

Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:

Hepatocellular damage (eg, hepatocyte ballooning and presence of Mallory-Denk bodies).

Inflammatory infiltrate (predominantly polymorphonuclear cells). Pericellular or sinusoidal fibrosis.

  • Hepatocellular carcinoma beyond Milan's criteria diagnosed during the first 7 days after inclusion.
  • Complete portal vein thrombosis diagnosed during the first 7 days after inclusion.
  • Protocol violation.
  • Severe adverse event directly related with Rifaximin.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Active comparator
    Prednisone

    Prednisone PO 40mg/day for 30 days plus standard supportive care measurements

    Drug: Prednisone

  • Experimental
    Prednisone plus Rifaximin

    Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements

    Drug: Prednisone · Drug: Rifaximin

Interventions

  • DrugPrednisone

    Prednisone PO 40mg/day or IV equivalent dosage for 30 days. Patients not responding at 7 days (e.g. Lille Model ≥ 0.45) treatment with Prednisone will be suspended.

  • DrugRifaximin

    Rifaximin PO 1200 mg/day for 90 days

06

What researchers measure

Primary outcomes

  1. Rate of bacterial infections

    Development of any bacterial infection.

    Time frame: 90 days

Secondary outcomes

  1. Rate of Decompensations of Liver Cirrhosis

    Development of any liver cirrhosis decompensations 1. Hepatic Encephalopathy 2. Acute Kidney Injury (including Hepatorenal Syndrome) 3. Acute variceal bleeding 4. Ascites 5. Death

    Time frame: 90 days

Other outcomes

  1. Endotoxemia serum levels

    Measurement of serum changes in endotoxemia levels during the rifaximin treatment.

    Time frame: 90 days

07

Study locations

4 sites
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Spain
  • Hospital del Mar
    Barcelona, Spain
  • Hospital Universitari Germans Trias i Pujol
    Barcelona, Spain
  • Vall d'Hebron Hospital
    Barcelona, Spain
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2014
First posted
Apr 17, 2014
Start
Apr 2013
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Nov 4, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02116556
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Germans Trias i Pujol Hospital, Hospital del Mar, Hospital de Sant Pau
Responsible party
Sponsor
First posted
Apr 17, 2014
Start date
Apr 2013
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Nov 4, 2016

Study contacts

Victor Vargas, MD
principal investigator · Internal Medicine Service. Vall d'Hebron Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Rifaximin

Other studies in this condition

Hepatitis, Alcoholic →

Other studies from this sponsor

Hospital Universitari Vall d'Hebron Research Institute →

Start the discussion