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Effects of rifaximin administration in patients with severe acute alcoholic hepatitis. Comparative pilot study.

Effects of rifaximin administration in patients with severe acute alcoholic hepatitis. Comparative pilot study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000515-80-ES
Enrollment
Unknown
Registered
2012-06-26
Start date
2012-08-29
Completion date
Unknown
Last updated
2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute alcoholic hepatitis MedDRA version: 14.1 Level: LLT Classification code 10000649 Term: Acute alcoholic hepatitis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: SPIRAXIN Pharmaceutical Form: Tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Sponsors

Juan Córdoba
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients> 18 and 32. - Confirmation of acute alcoholic hepatitis histology defined in the protocol 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Advanced or terminal chronic illness - Hepatocarcinoma - Complete portal thrombosis. - Autoimmune liver disease. - Infection with hepatitis B and C, or HIV. - Use of rifaximin in the last 2 months.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate whether the administration of rifaximin as an adjunct to corticosteroids decreases the number of bacterial infections in patients 90 days with acute alcoholic hepatitis.;Secondary Objective: - Effect of rifaximin in the response to corticosteroids after 7 days - Serum levels of endotoxemia and proinflammatory cytokines and chemotactic (chemokines) - Type of infections developed within the hospital, 30 and 90 days - Frequency and type of other complications of liver failure;Primary end point(s): bacterial infections;Timepoint(s) of evaluation of this end point: During hospitalization, 30 and 90 days—

Secondary

MeasureTime frame
Secondary end point(s): response to specific treatment and complications;Timepoint(s) of evaluation of this end point: at 7 days, and during hospitalization, 30 and 90 days—

Countries

Spain

Contacts

Public ContactSponsor and coordinator

Juan Córdoba

jcordoba@vhebron.net+34932746140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026