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New treatment option for Alcoholic Hepatitis
Official title Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
ClinicalTrials.gov ID: NCT05294744
What this study is testing
What is N-acetylcysteine?
N-acetylcysteine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alcoholic hepatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.
- Which group you join is decided by chance.
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 75
You may be able to join if
- Men and women.
- Age from 18 to 75 years.
- Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
- Maddrey score\> = 32.
- Acceptance of participation through written informed consent.
You likely can't join if
- Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
- Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
- Hepatocarcinoma.
- Portal cavernomatosis.
- Portal cavernomatosis.
- Any disease whose life expectancy is less than 12 months.
See the full eligibility criteria
- Men and women.
- Age from 18 to 75 years.
- Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
- Maddrey score\> = 32.
- Acceptance of participation through written informed consent.
- Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
- Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
- Hepatocarcinoma.
- Portal cavernomatosis.
- Portal cavernomatosis.
- Any disease whose life expectancy is less than 12 months.
- Patients with nitroglycerin and / or carbamazepine-based treatments.
- Patients with uncontrolled active infection.
- Acute kidney disease with creatinine\> 2.5 mg / dL.
- Uncontrolled upper gastrointestinal bleeding.
- Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis).
- Multiple organ failure or shock.
The study team makes the final eligibility decision.
Where it's taking place
- Vitoria-Gasteiz, Álava, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vitoria-Gasteiz, Álava, Spain. 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.