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Corticosteroids in Alcoholic Hepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03160651
Recruitment Status : Not yet recruiting
First Posted : May 19, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Brief Summary:
Approximately 50% of patients admitted for severe AH will have spontaneous improvement of liver function before initiation of therapy (ie decrease in mDF between hospital admission and initiation of steroids). These patients have a better prognosis than patients without spontaneous improvement of liver function. It has never been demonstrated that corticosteroids improve survival in severe AH patients with spontaneous improvement of liver function. Our hypothesis is that severe AH patients with spontaneous improvement of liver function represent a group who could most benefit from steroids

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Drug: Methylprednisolone or placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blind randomized trial Investigator, patients, and care providers will be masking Only statisticians and pharmacist will not be masking
Primary Purpose: Treatment
Official Title: Corticosteroids in Severe Alcoholic Hepatitis Patients With Early Spontaneous Improvement
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Active Comparator: methylprednisolone
Patients will receive 28 days of methylprednisolone 32 mg/day
Drug: Methylprednisolone or placebo
Patients will receive 28 days of methylprednisolone 32 mg/day

Placebo Comparator: placebo
Patients will receive 28 days of matching placebo
Drug: Methylprednisolone or placebo
Patients will receive 28 days of methylprednisolone 32 mg/day




Primary Outcome Measures :
  1. Mortality at 90 days [ Time Frame: 90 days ]
    To determine whether Methylprednisolone compared to placebo improve the 90 day mortality from patients with severe AH and spontaneous improvement of liver function


Secondary Outcome Measures :
  1. Mortality at 28 days [ Time Frame: 28 days ]
    To determine the 28 day mortality from patients with severe AH and spontaneous liver function improvement treated with Methylprednisolone or placebo

  2. Incidence of infections during the study period (90 days) [ Time Frame: 90 days ]
    To determine the incidence of infections during the 90 day study period in corticosteroid-treated compared to placebo-treated patients



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical syndrome of alcoholic hepatitis:

    recent jaudice or in recent aggravation (< 3 months) serum bilirubin > 5 mg/dL history of excess alcohol abuse (> 40g/day)

  2. Alcoholic hepatitis proven by a liver biopsy (histological criteria of alcoholic hepatitis defined according to EASL clinical practice guidelines : steatosis, hepatocyte ballooning, and an inflammatory infiltrate with PMNs)
  3. Spontaneous liver function improvement, defined by a decrease in mDF and serum bilirubin level > 10% between admission and day 7 after admission
  4. less than 2 weeks since admission to hospital
  5. Maddrey discriminant function* greater than or equal to 32
  6. Subjects must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study-specific procedures.
  7. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.

Patients with significant hepatic encephalopathy are not excluded from participation to the trial. In this case, the patient should be accompanied by a legal representative that will decide participation in the clinical study and sign ICF.

Exclusion Criteria:

  1. Other causes of liver disease including viral hepatitis (positive HBs antigen, HCV RNA positive), auto-immune hepatitis, biliary obstruction
  2. Other disease compromising 90-day survival
  3. Positive HIV serology
  4. Uncontrolled infection All patients will be screened for infection. This will involve chest radiography, urinalysis, PMNs count in ascites (if ascites present). All other sign or clinical suspicion of infection with or without antibiotherapy will be recorded as an infection.

    Positive culture and initiation of antibiotics with clinical or radiological signs of infection, as well as clinical suspicion, will be recorded as infection.

    Patients with evidence of sepsis will be treated for a minimum of 2 days with appropriate antibiotics. Once the local principal investigator considers that the sepsis is under control, the patient may be rescreened and randomised.

  5. Uncontrolled gastrointestinal bleeding Bleeding must be judged as controlled for at least 5 days
  6. Patient with serum creatinine > 2.5 mg/dL, under renal replacement therapy or under terlipressine (or other vasoactive drugs)
  7. Pentoxyphilline therapy
  8. Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160651


Contacts
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Contact: Christophe Moreno, MD, PhD +32 2 5553714 christophe.moreno@erasme.ulb.ac.be
Contact: Françoise Smits, Nurse +32 2 5554478 francoise.smits@erasme.ulb.ac.be

Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Christophe Moreno, MD, PhD Erasme University Hospital
Publications:

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03160651    
Other Study ID Numbers: CORTISAVE study
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Erasme University Hospital:
alcoholic hepatitis
spontaneous improvement
corticosteroids
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones