Health TrialsbyHealthPanel

Short Course Steroids in Alcohol Associated Hepatitis

ConditionAlcoholic Hepatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAsian Institute of Gastroenterology, India

About this trial

Alcohol-associated hepatitis (AAH) is one of the most severe manifestations of the spectrum of alcohol related liver disease (ARLD), with high morbidity and mortality. Currently, corticosteroids are the standard of care for patients with severe AAH, but no consensus exists on the dosing schedule of steroids. The investigators have recently demonstrated that tapering prednisolone over 4 weeks reduces the risk of infections at day 90. However, the investigators wanted to test whether the reduction in the duration of therapy would provide a similar benefit as tapering the dose of prednisolone. Therefore, the investigators planned to assess the impact of a shorter duration of prednisolone on outcomes, including the incidence of infections, survival and adverse events. One group will receive 7 days of prednisolone followed by a placebo for the next seven days, and the other group will receive 40 mg of prednisolone for 14 days. Prednisolone will be stopped in case of non-response and/or adverse events to the drug. All infections will be diagnosed by an ID specialist who is blind to the allocated group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with AAH aged between 18 and 80 years with a MELD score >21 and/or mDF >32 will be included.

Patients with infection at baseline will be included if they have controlled infection defined as afebrile for at least 48 hours, sterile cultures and procalcitonin < 1 ng/ml.

Disqualifiers

Age < 18 years, > 80 years

Active Infection

Persistent acute kidney injury (creatinine >1.5 mg/dl) or chronic kidney disease

Recent/ongoing bleed

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisolone 40 mg

    Drug

    Patients will be screened for infection till 90 days from the day of initiation of prednisolone. the three patient arms will be compared for severity scores of the disease, rate and severity of infections, diabetic control, post-treatment outcomes, and mortality.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Prednisolone dose of 40mg/day for 7 daysActive comparator 1 intervention
Group B: Prednisolone dose of 40mg/day for 14 daysActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants developing infection in each group

Infections will be assessed as defined priori. Infections will be compared among patient who respond to steroids and who do not.

Time frame
at day 28 and 90

Secondary outcomes

1

Mortality rate among the two groups

Proportion of patients dying within the specified time period

Time frame
day 90
2

Effiacy of prednisolone in each group

Defined as proportion of patients achieving model for end-stage liver disease (MELD) score \< 17. The minimum value of MELD is 6 and maximum is 40.

Time frame
day 28 and 90
3

Number of steroid responders in each group

response to prednisolone defined as Lille's \<0.45

Time frame
day 7
4

compare proportion of patients requiring readmission

readmission in each group at day 90

Time frame
day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asian Institute of Gastroenterology, India

Lead sponsor

Mahatma Gandhi Medical College

Collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

Collaborator

Kalinga Institute of Medical Sciences, Bhubaneswar

Collaborator

Apollo Gleneagles Hospitals, Kolkata

Collaborator

Source ClinicalTrials.gov
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