NCT03773887 Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
| NCT ID | NCT03773887 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Liver Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2014-12-25 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2014-12-25 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion 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 on the presence of the following histological characteristics: Hepatocellular lesions (ballooning, Mallory body)/ Inflammatory infiltrate with polymorphonuclear neutrophils * 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) Exclusion Criteria: * 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
Contact & Investigator
Philppe Mathurin, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT03773887 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03773887 currently recruiting?
Yes, NCT03773887 is actively recruiting participants. Contact the research team at philippe.mathurin@chru-lille.fr for enrollment information.
Where is the NCT03773887 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT03773887 clinical trial?
NCT03773887 is sponsored by University Hospital, Lille. The principal investigator is Philppe Mathurin, MD,PhD at University Hospital, Lille. The trial plans to enroll 450 participants.