Alcoholic HepatitisPhase 2RIFA-AAHNCT02116556
Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis
A Phase 2 study testing Prednisone and Rifaximin in people with Alcoholic Hepatitis, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Prednisone and Rifaximin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesSpain
- Study dates
- Apr 2013to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Universitari Germans Trias i Pujol
Barcelona
Vall d'Hebron Hospital
Barcelona
About this study
Official title: Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study
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:
- Primary endpoint: Bacterial infections after 90 days.
- Secondary endpoints: :
2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival
- Conditions
- Alcoholic Hepatitis
- Being tested
- Prednisone, Rifaximin
- Keywords
- Alcoholic Hepatitis, Bacterial Infections, Acute-on-Chronic Liver Failure
- Medical subject headings
- Hepatitis, Alcoholic, Bacterial Infections, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
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.
RifaximinDrug
Rifaximin PO 1200 mg/day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Active comparator | Prednisone PO 40mg/day for 30 days plus standard supportive care measurements Receives: Drug: Prednisone |
| Prednisone plus Rifaximin | Experimental | Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements Receives: Drug: Prednisone; Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bacterial infections
Development of any bacterial infection.
Measured: 90 days
Secondary outcomes (1)
Rate of Decompensations of Liver Cirrhosis
Development of any liver cirrhosis decompensations
- Hepatic Encephalopathy
- Acute Kidney Injury (including Hepatorenal Syndrome)
- Acute variceal bleeding
- Ascites
- Death
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital del Mar, Hospital de Sant Pau
- Responsible party
- Sponsor
- Investigators
- Victor Vargas, MD, Principal investigator, Internal Medicine Service. Vall d'Hebron Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116556
- Sponsor's protocol ID
- RIFA-AAH.
- Acronym
- RIFA-AAH
- Status last verified
- Nov 2016
- First submitted
- 15 Apr 2014
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study
- ClinicalTrials.gov ID
- NCT02116556
- Acronym / sponsor ID
- RIFA-AAH / RIFA-AAH.
- Conditions
- Alcoholic Hepatitis
- Keywords
- Alcoholic Hepatitis, Bacterial Infections, Acute-on-Chronic Liver Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital del Mar, Hospital de Sant Pau
- Study start
- Apr 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Primary endpoint: Bacterial infections after 90 days.
- Secondary endpoints: :
2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: PrednisonePrednisone PO 40mg/day for 30 days plus standard supportive care measurements |
| Prednisone plus Rifaximin | Experimental | Drug: Prednisone, Drug: RifaximinPrednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisonePrednisone 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. | Drug | Prednisone, Prednisone plus Rifaximin |
| RifaximinRifaximin PO 1200 mg/day for 90 days | Drug | Prednisone plus Rifaximin |
Primary outcome
Rate of bacterial infections
Time frame: 90 days
Development of any bacterial infection.
1 secondary outcome
Rate of Decompensations of Liver Cirrhosis
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Vargas, MD principal investigator
Internal Medicine Service. Vall d'Hebron Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone and Rifaximin in people with Alcoholic Hepatitis, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bacterial infections (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.