Utility of the use of N-acetylcisteine associated with conventional treatment in patients with severe acute alcoholic hepatitis (Maddrey>=32)

Status Authorised, recruitment pending · 1 EU/EEA countries · 9 sites · Protocol CONACHAA

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruitment pending

Participants planned 180

Countries 1

Sites 9

Acute Alcoholic hepatitis

To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Alcoholic Hepatitis

Key facts

Sponsor: Asociacion Instituto De Investigacion Sanitaria Bioaraba
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Decision date (initial): 2025-01-15
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2023-510163-35-00
EudraCT number: 2020-004549-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Alcoholic Hepatitis

Secondary objectives 4

To asses mortality at three months and six months
To assess liver complications, infections and renal failure
To assess the tolerance to N-acetilcisteína
To assess the relationship between the Lille index at day 7 and the response to treatment

Conditions and MedDRA coding

Acute Alcoholic hepatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

Males and females
Age from 18 to 75 years.
Diagnosed with acute alcoholic hepatitis per AASLD guidelines or compatible liver histology
Maddret Score >= 32
Willingness to participate expressed through written informed consent

Exclusion criteria 11

Alternate cause of jaundice
Allergy or intolerance to NAC and/or corticosteroids
Hepatocellular carcinoma
Pregnancy
Life expectancy under 12 months due to comorbid conditions
Current treatment with nitroglycerin and/or carmazepine
Uncontrolled active infections
Acute renal failure with creatinine > 2,5 mg/dL
Uncontrolled upper gastrointestinal bleeding
Uncontrolled concomitan diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis)
Multiple organ failure or shock

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Acute Alcoholic Hepatitis

Secondary endpoints 4

To assess mortality at three months and six months
To assess liver complications, infections and renal failure
To assess the tolerance to NAC
To assess the relationship between the Lille index at day 7 and the response to treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Acetylcysteine

SCP112617546 · ATC

Active substance: Acetylcysteine
Substance synonyms: L-ALPHA-ACETAMIDO-BETA-MERCAPTOPROPIONIC ACID, N-ACETYLCYSTEINE, N-ACETYL-L-CYSTEINE
Route of administration: INTRAVENOUS PERFUSION USE
Max daily dose: 150 mg/kg milligram(s)/kilogram
Max total dose: 150 mg/kg milligram(s)/kilogram
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: V03AB23 — ACETYLCYSTEINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lidocaine Hydrochloride Monohydrate

SCP101878658 · ATC

Active substance: Lidocaine Hydrochloride Monohydrate
Route of administration: INTRAVENOUS PERFUSION USE
Max daily dose: 32 mg milligram(s)
Max total dose: 224 mg milligram(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: H02AB04 — METHYLPREDNISOLONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Asociacion Instituto De Investigacion Sanitaria Bioaraba

Sponsor organisation: Asociacion Instituto De Investigacion Sanitaria Bioaraba
Address: Jose Achotegui Kalea S/n 4º C
City: Vitoria
Postcode: 01009
Country: Spain

Scientific contact point

Organisation: Asociacion Instituto De Investigacion Sanitaria Bioaraba
Contact name: Maria Cabero

Public contact point

Organisation: Asociacion Instituto De Investigacion Sanitaria Bioaraba
Contact name: Maria Cabero

Locations

1 EU/EEA country · 9 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Authorised, recruitment pending	180	9
Rest of world	—	0	—

Investigational sites

Spain

9 sites · Authorised, recruitment pending

Hospital Universitario Basurto

Digestivo, Montevideo Etorbidea 16-18, 48013, Bilbao

Hospital Universitario De Leon

Digestivo, Calle Altos De Nava S/n, 24071, Leon

Hospital Universitario De Salamanca

Digestivo, Paseo De San Vicente 58-182, 37007, Salamanca

Hospital Universitario Donostia

Digestivo, Pasealeku Doct. Begiristain 109, 20014, Donostia

Hospital Universitario Miguel Servet

Digestivo, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza

Hospital De Galdakao Usansolo

Digestivo, Leku Barrio Labeaga 46 A, 48960, Galdakao

Hospital Universitario Araba

Digestivo, Jose Achotegui Kalea S/N, 01009, Vitoria

Hospital El Bierzo

Digestivo, Calle Medicos Sin Fronteras 7, Poligono Industrial El Bierzo, Ponferrada

Hospital San Pedro

Digestivo, Calle Piqueras 98, 26006, Logrono

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol	1
Recruitment arrangements (for publication)	K1_Recruitment arragements	1
Subject information and informed consent form (for publication)	L1_SIS and ICF	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-01-09	Spain	Acceptable 2025-01-15	2025-01-15