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Official title Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
ClinicalTrials.gov ID: NCT03773887
What this study is testing
- What it's testing
- The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- group A: patients with acute alcoholic hepatitis
- Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (\> 60 g per day for men and\> 40 g per day for women)
- Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT ratio of 2: 1
- Bilirubin\> 50 mg / l
- Absence of autoimmune liver disease (ANA \<1/80, AML \<1/80, LKM1 neg, AAM neg)
You likely can't join if
- For groups A and B1:
- Patients with hepatocellular carcinoma of progressive non-hepatic cancer
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
- Pregnancy
See the full eligibility criteria
- group A: patients with acute alcoholic hepatitis
- Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (\> 60 g per day for men and\> 40 g per day for women)
- Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT ratio of 2: 1
- Bilirubin\> 50 mg / l
- Absence of autoimmune liver disease (ANA \<1/80, AML \<1/80, LKM1 neg, AAM neg)
- Absence of hepatitis B and C and HIV infection (negative anti-HIV antibodies, negative HBsAg, negative HCV PCR)
- Patients with other acute complications than alcoholic hepatitis may be included (eg, digestive hemorrhage, acute renal failure, infection, etc.)
- Because there is no validated noninvasive tool for the diagnosis of alcoholic hepatitis, histological confirmation is required in all patients (preferably by transjugular biopsy): alcoholic hepatitis will be diagnosed...
- group B1: patients with alcoholic cirrhosis
- Decompensated or non-decompensated alcoholic cirrhosis, defined according to the HAS guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments (www.has-sante.fr)
- group B2: patients free from chronic liver disease
- Justification of blood and liver sampling for the management of a pathology other than chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy liver)
- For groups A and B1:
- Patients with hepatocellular carcinoma of progressive non-hepatic cancer
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
- Pregnancy
- for group B2:
- Alcoholic liver disease
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.