Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone

Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00863785

Acronym

HAA-NAC

Enrollment

174

Registered

2009-03-18

Start date

2004-04-30

Completion date

2009-09-30

Last updated

2009-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

Acute Alcoholic Hepatitis, Cirrhosis, Alcohol, Alcoholic Liver disease

Brief summary

35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7

Detailed description

AAH patients (Maddrey score \> 32 and compatible histological results) should centrally randomized into the C-NAC or C groups. Both groups received 4 weeks of prednisolone treatment, plus NAC for the combination therapy group (D1: 150, 50 and 100 mg/kg in 250, 500 and 1000 mL of 5% glucose-saline (G5%) respectively, at t=30 minutes, 4 and 16 hours; D2 to D5, 100 mg/kg in 1000 mL of G5%). Group C received 1000 mL of G5%, D1-5

Interventions

DRUGCorticoids plus N Acetyl Cysteine

40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patient consent * Chronic alcohol intake in the last 3 to 6 months * Maddrey score ≥ 32 * Liver histology compatible

Exclusion criteria

* Hepato renal syndrome * Hepatocarcinoma * Recent variceal haemorrhage * Recent bacterial infections * Other liver diseases associated (HCV, HBV, hemochromatosis, AIH) * Cancers or cardiac and respiratory, HIV infection * NAC Allergy * No patient consent * Acetaminophen intoxication

Design outcomes

Primary

Measure	Time frame
Survival at one, three and six months	six months

Secondary

Measure	Time frame
bilirubin decrease at day seven survival at one and three months nac tolerance side effects	one, three and six months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026