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NCT06855667
Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis.
NA trial testing Plasma Exchange in Autoimmune Hepatitis in 50 participants. Not yet recruiting.
28 February 2027
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 3 March 2025 |
| Primary completion | 28 February 2027 |
| Estimated completion | 28 February 2027 |
| Sites | 1 location across India |
Drugs / interventions tested
- Plasma Exchange — full drug profile →
- Steroid
- Diet
Conditions studied
- Autoimmune Hepatitis — all drugs for Autoimmune Hepatitis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 60, any sex, with Autoimmune Hepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. As a heterogeneous disease, AIH presents variably in different patients, making diagnosis and treatment a challenge.It is associated with varied clinical presentations and natural history and somewhat unpredictable treatment responses. Steroids and immunosupressants are main stay of treatment.In acute severe presentations corticosteroid response rates are more variable.According to treatment guidelines if patients fail to respond to corticosteroids, Liver transplant is the only option. But Liver transplant is not feasible in all situations such as limited donor availability.Plasma exchange is associated with a reduction in levels of pro-inflammatory cytokines,DAMPs, and bacterial endotoxins and increase in the levels of anti-inflammatory cytokines.Plasma exchange has reportedly been used for acute presentations of AIH but there are few trials which prove its independent benefit and role in influencing transplant free survival.The study aims at proving the efficacy of Plasma exchange as a bridge between steroid therapy and Liver transplant.It includes the patients with acute severe autoimmune hepatitis .One group of patients are taken up for plasma exchange sessions and compared with the other group started on high dose of steroids and they will be observed for 28 days and are assessed for transplant free survival and efficacy of plasma exchange in reducing transaminitis and Bilirubin levels.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06855667
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Related trials
Other trials of Plasma Exchange
Trials testing the same drug.
- NCT06698991 — Daily Versus Alternate Day Plasma Exchange in Wilson Disease With Acute Liver Failure in Children · NA · not yet recruiting
- NCT06355726 — Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Fun · NA · unknown
- 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 Autoimmune Hepatitis
Currently open trials in the same condition.
- NCT06381453 — Belimumab in Autoimmune Hepatitis · Phase 2 · recruiting
- NCT06455280 — A Study of SIPLIZUMAB in AILD and LT Patients · Phase 1 · recruiting
- NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome · recruiting
- NCT06250309 — Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients · NA · recruiting
- NCT06078098 — Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage · 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 NCT06855667 (US National Library of Medicine, public domain)
- 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: 4 March 2025
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