N-Acetylcysteine in Severe Acute Alcoholic Hepatitis | NCT00962442

Studies
N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

NCT00962442

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Aug 20, 2009Estimated

Enrollment

44Actual

Phase

Phase 3

Conditions

Alcoholic Hepatitis

Interventions

N-Acetylcysteine
placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2000

Primary Completion Date

Jan 2006Actual

Completion Date

Not provided

First Submitted Date

Aug 19, 2009

First Submission Date that Met QC Criteria

Aug 19, 2009

First Posted Date

Aug 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2009

Last Update Posted Date

Aug 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and is associated with a high risk of dying in the short term. Corticosteroids are generally recommended in patients with severe AAH, but its use is still controverted and contraindicated in case of active infection or gastrointestinal bleeding. Therefore, alternative therapeutic options are needed.Ethanol consumption results in the depletion of endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant deficiencies.Due to its effects on glutathion stores restoration and as such the limitation of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might be beneficial in severe AAH.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nutritional support + N-Acétylcysteine	Active Comparator	N-Acétylcysteine 300 mg/kg intravenously for 14 days Beside usual meals, patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days	Drug: N-Acetylcysteine
nutritional support + placebo	Placebo Comparator	placebo perfusion for 14 days Beside usual meals patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-Acetylcysteine	Drug	300 mg/kg for 14 days, intravenously	nutritional support + N-Acétylcysteine

Measure	Description	Time Frame
Six months survival

Measure	Description	Time Frame
Rate of infections, clinical and biological parameters

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy proven alcoholic hepatitis
Severe disease defined by a Maddrey score superior to 32

Exclusion Criteria:

Neoplastic disease compromising 6 months survival
HIV patients
Hepatorenal syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasme University Hospital		Brussels		1070	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D006519	Hepatitis, Alcoholic

Ancestor Terms

ID	Term
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D008108	Liver Diseases, Alcoholic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided