Alcoholic HepatitisNCT02796469
Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis
An observational study of Alcoholic Hepatitis and Alcoholic Liver Disease, run by University Hospital, Lille.
Trial summary
In the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a DF ≥ 32. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Hepatitis, Alcoholic Liver Disease
- What is being tested?
- Pentoxifylline and Corticosteroid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,974 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe alcoholic hepatitis assessed by Discriminant Function (DF) ≥32.
Who may be able to join
- patients included in 10 randomized controlled trials testing either corticosteroids alone, or pentoxifylline alone or their combination have been published.
Who cannot join
- -
About this study
Official title: Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Ten Clinical Trials Comparing Drug Therapy in Patients With Severe Alcoholic Hepatitis
In the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both univariate and multivariate analyses, truth survival is lower for conclusions from meta-analysis of the literature than for conclusions derived from non-meta-analyses.
The present study is a meta-analysis of individual data from RCTs restricted to patients with a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving either corticosteroids, or pentoxifylline or their combination to those of patients not receiving them adjusted on the independent prognostic factors at baseline.
The secondary endpoints will be: a) assessment of response to the assigned treatment using the Lille model; b) analysis of 6-month survival according to allocated therapy.
- Conditions
- Alcoholic Hepatitis, Alcoholic Liver Disease
- Being tested
- Pentoxifylline, Corticosteroid, Placebo
- Medical subject headings
- Hepatitis, Alcoholic, Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
CorticosteroidDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline + Corticosteroid | Association of treatment by pentoxifylline and corticosterone during 28 days Receives: Drug: Pentoxifylline; Drug: Corticosteroid | |
| Corticosteroid | treatment by corticosteroid during 28 days Receives: Drug: Corticosteroid; Drug: Placebo | |
| Pentoxifylline | treatment by pentoxifylline during 28 days Receives: Drug: Pentoxifylline; Drug: Placebo | |
| Placebo | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: at 28 days, after the first administration of treatment
Secondary outcomes (2)
Lille Model Score
Lille model evaluate to therapy and will be analyzed as dichotomous outcome (<0.45 vs. ≥0.45), ordinal outcome (≤0.16 vs. 0.16-0.56 vs. ≥ 0.56) and continuous outcome (after log-transformation) and will be restricted to patients with a dosage of bilirubin at day 7 after initiation of assignment treatment.
Measured: at day 7, after the first administration of treatment
Biological measure : Bilirubin
evaluate of bilirubin during treatment period
Measured: at day 7, at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionMay 2016
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 University Hospital, LilleThe 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
- Observational
- Enrolment
- 1,974 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Mathurin, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796469
- Sponsor's protocol ID
- MA_2016-01
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Ten Clinical Trials Comparing Drug Therapy in Patients With Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02796469
- Acronym / sponsor ID
- MA_2016-01
- Conditions
- Alcoholic Hepatitis, Alcoholic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,974 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jun 2016 (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.
In the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both univariate and multivariate analyses, truth survival is lower for conclusions from meta-analysis of the literature than for conclusions derived from non-meta-analyses.
The present study is a meta-analysis of individual data from RCTs restricted to patients with a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving either corticosteroids, or pentoxifylline or their combination to those of patients not receiving them adjusted on the independent prognostic factors at baseline.
The secondary endpoints will be: a) assessment of response to the assigned treatment using the Lille model; b) analysis of 6-month survival according to allocated therapy.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline + Corticosteroid | – | Drug: Pentoxifylline, Drug: CorticosteroidAssociation of treatment by pentoxifylline and corticosterone during 28 days |
| Corticosteroid | – | Drug: Corticosteroid, Drug: Placebotreatment by corticosteroid during 28 days |
| Pentoxifylline | – | Drug: Pentoxifylline, Drug: Placebotreatment by pentoxifylline during 28 days |
| Placebo | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe alcoholic hepatitis assessed by Discriminant Function (DF) ≥32.
Key inclusion criteria (1 listed)
- patients included in 10 randomized controlled trials testing either corticosteroids alone, or pentoxifylline alone or their combination have been published.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Pentoxifylline | Drug | Pentoxifylline, Pentoxifylline + Corticosteroid |
| Corticosteroid | Drug | Corticosteroid, Pentoxifylline + Corticosteroid |
| Placebo | Drug | Corticosteroid, Pentoxifylline |
Primary outcome
Overall survival
Time frame: at 28 days, after the first administration of treatment
2 secondary outcomes
Lille Model Score
Time frame: at day 7, after the first administration of treatment
Biological measure : Bilirubin
Time frame: at day 7, at day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Mathurin, MD, PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Hepatitis and Alcoholic Liver Disease, run by University Hospital, Lille.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: at 28 days, after the first administration of treatment). 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 10 Jun 2016.