Back to resultsUtility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Primary Purpose
Alcoholic Hepatitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis
Eligibility Criteria
Inclusion 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Ana Belén Fernández Laso
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Corticosteroids
Corticosteroids + N-acetylcysteine
Arm Description
Corticosteroids following Standard Clinical Practice
Corticosteroids following Standard Clinical Practice plus N-acetylcisteine
Outcomes
Primary Outcome Measures
Number of Participants with all-cause mortality at 6 months.
Main result variable.
Secondary Outcome Measures
Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.
Security variable.
Full Information
NCT ID
NCT05294744
First Posted
July 14, 2021
Last Updated
March 23, 2022
Sponsor
Bioaraba Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05294744
Brief Title
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Official Title
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bioaraba Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects.
Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use.
Clinical, randomized, controlled, multicenter, parallel and open trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical, randomized, controlled, multicenter, parallel and open trial.
Masking
None (Open Label)
Masking Description
This is an open trial.
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroids
Arm Type
Active Comparator
Arm Description
Corticosteroids following Standard Clinical Practice
Arm Title
Corticosteroids + N-acetylcysteine
Arm Type
Experimental
Arm Description
Corticosteroids following Standard Clinical Practice plus N-acetylcisteine
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously.
Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.
Primary Outcome Measure Information:
Title
Number of Participants with all-cause mortality at 6 months.
Description
Main result variable.
Time Frame
6 months.
Secondary Outcome Measure Information:
Title
Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.
Description
Security variable.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Belén Fernández, Clinic
Phone
945007000
Email
anabelen.fernandezlaso@osakidetza.eus
First Name & Middle Initial & Last Name or Official Title & Degree
Inés Pérez, Coordinator
Phone
945007000
Email
ines.perezfrancisco@osakidetza.eus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Belén Fernández, Clinic
Organizational Affiliation
HUA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ana Belén Fernández Laso
City
Vitoria-Gasteiz
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Belén Fernández, Clinic
Phone
945007000
Email
anabelen.fernandezlaso@osakidetza.eus
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no a plan to make individual participant data (IPD) available to other researchers.
Learn more about this trial
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
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