Alcoholic HepatitisPhase 3HAA-NACNCT00863785
Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone
A Phase 3 study testing Corticoids plus N Acetyl Cysteine in people with Alcoholic Hepatitis, run by Centre Hospitalier Universitaire, Amiens at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Corticoids plus N Acetyl Cysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 13 sitesFrance
- Study dates
- Apr 2004to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient consent
- Chronic alcohol intake in the last 3 to 6 months
- Maddrey score ≥ 32
- Liver histology compatible
Who cannot join
- 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
Show all 9Show fewer
- NAC Allergy
- No patient consent
- Acetaminophen intoxication
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre Hospitalier d'Abbeville
Abbeville
Centre Hospitalier Beauvais
Beauvais, 60000
Centre Hospitalier Universitaire de Besançon
Besançon, 25030
Centre Hospitalier Universitaire de Caen
Caen, 14000
Centre Hospitalier de Cambrai
Cambrai
Centre Hospitalier de Compiègne
Compiègne
Centre Hospitalier de Lens
Lens
Centre Hospitalier Saint-Antoine
Paris
Centre Hospitalier Universitaire Pitié-Salpétrière
Paris
Centre Hospitalier Universitaire de Reims
Reims
Centre Hospitalier Universitaire de Rouen
Rouen, 76031
Centre Hospitalier de Saint-Quentin
Saint-Quentin
Centre Hospitalier de Valenciennes
Valenciennes
About this study
Official title: Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.
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
Read the 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
- Conditions
- Alcoholic Hepatitis
- Being tested
- Corticoids plus N Acetyl Cysteine
- Keywords
- Acute Alcoholic Hepatitis, Cirrhosis, Alcohol, Alcoholic Liver disease
- Medical subject headings
- Hepatitis, Alcoholic, Fibrosis, Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticoids plus N Acetyl CysteineDrug
Also called AAH-NAC study
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 group | Role | What they receive |
|---|---|---|
| Corticoids plus N Acetyl Cysteine | Experimental | 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 Receives: Drug: Corticoids plus N Acetyl Cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at one, three and six months
Measured: six months
Secondary outcomes (1)
bilirubin decrease at day seven survival at one and three months nac tolerance side effects
Measured: one, three and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startApr 2004
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Investigators
- Phillippe DOMY, Study director, Centre Hospitalier Universitaire, Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863785
- Sponsor's protocol ID
- PHRC R04 - Dr NGUYEN-KHAC
- Other IDs
- AFSSAPS 040276
- Acronym
- HAA-NAC
- Status last verified
- Oct 2009
- First submitted
- 17 Mar 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.
PubMed 22070475
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT00863785
- Acronym / sponsor ID
- HAA-NAC / PHRC R04 - Dr NGUYEN-KHAC
- Conditions
- Alcoholic Hepatitis
- Keywords
- Acute Alcoholic Hepatitis, Cirrhosis, Alcohol, Alcoholic Liver disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corticoids plus N Acetyl Cysteine | Experimental | Drug: Corticoids plus N Acetyl Cysteine40 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient consent
- Chronic alcohol intake in the last 3 to 6 months
- Maddrey score ≥ 32
- Liver histology compatible
Key exclusion criteria (9 listed)
- Hepato renal syndrome
- Hepatocarcinoma
- Recent variceal haemorrhage
- Recent bacterial infections
- Other liver diseases associated (HCV, HBV, hemochromatosis, AIH)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticoids plus N Acetyl CysteineAlso: AAH-NAC study40 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 | Drug | Corticoids plus N Acetyl Cysteine |
Primary outcome
Survival at one, three and six months
Time frame: six months
1 secondary outcome
bilirubin decrease at day seven survival at one and three months nac tolerance side effects
Time frame: one, three and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
- Derived from this study: PubMed 22070475Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillippe DOMY study director
Centre Hospitalier Universitaire, Amiens
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corticoids plus N Acetyl Cysteine in people with Alcoholic Hepatitis, run by Centre Hospitalier Universitaire, Amiens at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at one, three and six months (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.