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NCT06355726
Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function
NA trial testing Plasma Exchange in Alcoholic Hepatitis in 60 participants. Status unknown.
28 February 2025
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 9 April 2024 |
| Primary completion | 28 February 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 1 location across India |
Drugs / interventions tested
- Plasma Exchange — full drug profile →
- Standard Medical Treatment — full drug profile →
Conditions studied
- Alcoholic Hepatitis — all drugs for Alcoholic Hepatitis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 60, any sex, with Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Clinical Trials for Alcohol-Associated Hepatitis.
Rady ED, Anouti A, Mitchell MC, Cotter TG. · · 2026 · cited 3× · PMID 40254132 · DOI 10.1016/j.ajpath.2025.03.009 -
Emerging therapeutic regimens as alternatives to glucocorticoids for severe alcohol-associated hepatitis: a comprehensive review.
Kumar R, Elangovan S, Asrani SK. · · 2026 · cited 1× · PMID 41715264 · DOI 10.3350/cmh.2025.1163
Verify or expand the search:
- PubMed search for NCT06355726
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Plasma Exchange
Trials testing the same drug.
- NCT06855667 — Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis. · NA · not yet recruiting
- NCT06698991 — Daily Versus Alternate Day Plasma Exchange in Wilson Disease With Acute Liver Failure in Children · NA · not yet recruiting
- NCT06276907 — An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Or · NA · not yet recruiting
- NCT04871035 — Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS) · recruiting
- NCT04302805 — rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transpl · Phase 3 · completed
Other recruiting trials for Alcoholic Hepatitis
Currently open trials in the same condition.
- NCT06919458 — Short Course Steroids in Alcohol Associated Hepatitis · Phase 3 · recruiting
- NCT06307964 — Intra-Hepatic Microbiota in Alcoholic Hepatitis · recruiting
- NCT05006430 — Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis · Phase 1, PHASE2 · recruiting
- NCT05018481 — HA35 Moderate Alcoholic Hepatitis (AH) Study · EARLY_PHASE1 · recruiting
- NCT02473341 — Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis · Phase 3 · active not recruiting
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
- NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06355726 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 24 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06355726.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing