Clinical Trial Results:
Effects of rifaximin administration in patients with severe acute alcoholic hepatitis. Comparative pilot study.
Summary
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EudraCT number |
2012-000515-80 |
Trial protocol |
ES |
Global end of trial date |
03 Nov 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Dec 2021
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First version publication date |
19 Dec 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RIFA-AAH
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02116556 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
VHIR
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Sponsor organisation address |
Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
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Public contact |
Joaquin Lopez-Soriano
, VHIR, +34 934894779, joaquin.lopez.soriano@vhir.org
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Scientific contact |
Sponsor and coordinator, Juan Córdoba, +34 932746140, jcordoba@vhebron.net
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Nov 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Nov 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
At all time points and during follow-up visits, physical examination, laboratory measurements, presence of bacterial infections, and any liver-related complications were surveyed, including presence or worsening of ascites, gastrointestinal bleeding (GIB), and acute-on-chronic liver failure (ACLF)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 63
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Worldwide total number of subjects |
63
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EEA total number of subjects |
63
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
55
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
The study included 21 consecutive patients recruited from June 2013 to June 2015 who were admitted to four tertiary hospitals in Barcelona. Treated patients were compared with a carefully matched historical cohort of patients treated with standard therapy and paired by age and model for end-stage liver disease (MELD). | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
63 | |||||||||
Number of subjects completed |
63 | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Prednisone | |||||||||
Arm description |
Prednisone plus standard supportive care measurements | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Prednisone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Prednisone PO 40mg/day for 30 days plus standard supportive care measurements
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Arm title
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Rifamixin | |||||||||
Arm description |
Rifaximin PO 1200 mg/day for 90 days added to standard treatment | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Rifamixin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Rifaximin PO 1200 mg/day for 90 days
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Prednisone
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Reporting group description |
Prednisone plus standard supportive care measurements | ||
Reporting group title |
Rifamixin
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Reporting group description |
Rifaximin PO 1200 mg/day for 90 days added to standard treatment |
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End point title |
Bacterial infections at 90 days | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
90 days
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Statistical analysis title |
Infections at 90 days | ||||||||||||
Comparison groups |
Prednisone v Rifamixin
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
De novo ACLF | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
90 days
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Statistical analysis title |
ACLF de novo | ||||||||||||
Comparison groups |
Prednisone v Rifamixin
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
= 0.81 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
Liver-related complication | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
90 days
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Statistical analysis title |
Liver complications/patient | ||||||||||||
Comparison groups |
Prednisone v Rifamixin
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.01 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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End point title |
Infection-free survival time | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
90 days
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Statistical analysis title |
Infection-free survival time | ||||||||||||
Comparison groups |
Prednisone v Rifamixin
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
= 0.12 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Total complications | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
90 days
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Statistical analysis title |
Total complications | ||||||||||||
Comparison groups |
Prednisone v Rifamixin
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
= 0.01 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
90 days
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
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Reporting group title |
Rifamixin treated
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
This was a pilot study, so it was underpowered by the sample size. Further studies with bigger populations should confirm these results. |