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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004549-35 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroids | Active Comparator | Corticosteroids following Standard Clinical Practice |
|
| Corticosteroids + N-acetylcysteine | Experimental | Corticosteroids following Standard Clinical Practice plus N-acetylcisteine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with all-cause mortality at 6 months. | Main result variable. | 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation. | Security variable. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Belén Fernández, Clinic | Contact | 945007000 | anabelen.fernandezlaso@osakidetza.eus | |
| Inés Pérez, Coordinator | Contact | 945007000 | ines.perezfrancisco@osakidetza.eus |
| Name | Affiliation | Role |
|---|---|---|
| Ana Belén Fernández, Clinic | HUA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ana Belén Fernández Laso | Recruiting | Vitoria-Gasteiz | Álava | 01009 | Spain |
There is no a plan to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Clinical, randomized, controlled, multicenter, parallel and open trial.
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This is an open trial.
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| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |