Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function

NCT06355726 | Recruiting

• 1 other identifier: ILBS-Alcoholic Hepatitis-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.\[1\] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.\[2,8\] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation.

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Liver transplant free survival at 28 days, 90 days and 180 days.

  28 days, 90 days and 180 days

Secondary Outcomes (10)

• Change in total bilirubin and INR as measured by Discriminant Functions

  28 days, 90 days and 180 days

• Number of patients with change in Model for End Stage Liver Disease (MELD)

  28 days, 90 days and 180 days

• Number of patients with change in CTP

  28 days, 90 days and 180 days

• Number of patients with change in LSM,SSM

  28 days, 90 days and 180 days

• Mortality in both groups

  28 days, 90 days and 180 days

Study Arms (2)

PLEX with SMT

EXPERIMENTAL

3 sessions to 5 max, alternate day with SMT

Biological: Plasma Exchange; Other: Standard Medical Treatment

SMT

ACTIVE COMPARATOR

High calorie intake 35 to 40 Kcal/kg, protein 1.2 to 1.5 g/kg,albumin,antibiotics as required

Other: Standard Medical Treatment

Interventions

Plasma Exchange BIOLOGICAL

Plasma exchange session will be done on alternate day to a maximum of 5 sessions. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session,no improvement in clinical condition and Intolerant to PLEX procedure

PLEX with SMT

Standard Medical Treatment OTHER

Standard Medical Treatment

PLEX with SMT; SMT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 60 years
• Severe alcoholic hepatitis with DF\>80\< 120 or MELD \>30
• No liver transplant option available in near future(for atleast 1 month)
• Patient able to bear the cost of Plasma exchange by himself/herself

You may not qualify if:

• Active sepsis
• S creatinine \>1.5mg/dl
• Chronic kidney disease
• Pregnancy
• HCC or any other malignancy
• Active Bleeding
• Allergic to replacement fluid (FFP) in TPE
• Severe Hypocalcemia (\<7.6 mg/dl)
• Failure to give consent
• Financial issues to bear cost of Plasma exchange

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

Dr Jitendra Kumar Singh, MD

CONTACT

01146300000; jitendra2602kc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: April 9, 2024
• Study Start: April 9, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-02

Locations

IN (1)