An interventional study of Plasma Exchange and Standard Medical Treatment in Acute Liver Failure and Wilson Disease, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
Among 12 studies in Liver Failure, Acute by Institute of Liver and Biliary Sciences, India — 3 open to participants now, 3 under way, none of them phase 3. Liver Failure, Acute · Institute of Liver and Biliary Sciences, India.
Among the 12 studies in Liver Failure, Acute by Institute of Liver and Biliary Sciences, India, this one is the 9th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2024, is one of 10 with no phase, and was the 11th registered.
96 studies on the registry are indexed under Liver Failure, Acute; 20 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 49 interventional studies indexed under Liver Failure, Acute.
Browse Liver Failure, Acute studies →3 of the 12 studies in Liver Failure, Acute by Institute of Liver and Biliary Sciences, India are open now, in 1 country. Each count lists the studies.
Of the 8 Liver Failure, Acute studies recruiting now, 3 (38%) set no upper age limit and 5 (63%) stop at 75 or younger; 2 take children under 18; 1 take healthy volunteers.
This study: 3 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2024.
Median enrollment 40 across the 10 interventional studies, 311 across the 2 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
2 of the studies in Liver Failure, Acute by Institute of Liver and Biliary Sciences, India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06831643Institute of Liver and Biliary Sciences, IndiaStandard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure | 2026-12-31 |
| NCT06698991Institute of Liver and Biliary Sciences, IndiaDaily Versus Alternate Day Plasma Exchange in Wilson Disease With Acute Liver Failure in Children | 2026-12-31 |
Among the 12 studies in Liver Failure, Acute by Institute of Liver and Biliary Sciences, India, from their registry updates:
Nothing recorded among them since 2026-09-25.
Wilson disease in children has a varied presentation. Wilson disease with acute liver failure is associated with very high mortality and morbidity. The standard therapy i.e chelation (with either D- penicillamine or trientene can be used as a temporizing agent to treat the enormous release of copper into the blood stream; however, substantial removal is not achieved for at least 1 to 3 months. Plasma exchange provides a means of rapid means of removal of copper. As per American Society for Apheresis, TPE in wilson disease with acute liver failure can rapidly remove an average of 20 mg of copper per TPE treatment. Decreased serum copper may decrease hemolysis, prevent progression of kidney failure and provide clinical stabilization. TPE can also remove large molecular weight toxins (aromatic amino acids, ammonia, endotoxins) and other factors, which may be responsible for hepatic coma. The frequency of said TPE is not defined as most evidence is based on case reports and case series.
Copper is highly protein bound and the volume of distribution for copper is large. Under normal conditions, 90-95% of serum copper is ceruloplasmin-bound with the remaining 5-10% being nonceruloplasmin-bound. TPE efficiently removes both ceruloplasmin- and albumin-bound copper. FFP used for exchange can be helpful in treating the associated coagulopathy. TPE has been used as a bridge to liver transplantation as well as seen to improve survival with native liver, the optimum protocol for same remains uncertain.
Study population: Children aged 3 to 18 years with Wilson disease (diagnosed as per Leipzig score >=4) with fulminant presentation (as defined by New Wilson Index>= 11 and INR >= 2.5 ).
Adverse effects: Therapeutic plasma exchange has been shown to be safe and effective in improving native liver survival in Wilson disease patients and is currently standard of care in patients with wilson disease with acute liver failure. However, TPE can be associated with risk of adverse events like infections, fluid overload or circulatory insufficiency, hypersensitivity to blood products.
Stopping rule:
Intervention:
Group 1: Daily plasma exchange + SMT (Maximum 3+1 sessions during a period of 7 days) Group 2: Alternate day therapeutic plasma exchange + SMT
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(Maximum 3+1 sessions during a period of 7 days)
Biological: Plasma Exchange · Other: Standard Medical Treatment
Alternate day therapeutic plasma exchange + SMT
Biological: Plasma Exchange · Other: Standard Medical Treatment
• Plasma exchange (1.5 times plasma exchange) * Blood volume: 80ml/kg * Plasma volume = Blood volume x (1 - Hematocrit/100) * TPE volume = 1.5 x plasma volume * Duration: 4 hours
Standard Medical Treatment
To compare the reduction in NWI (New Wilson Index) between both groups at the end of three sessions of plasma exchange
The New Wilson Index is a composite score containing of bilirubin, albumin, INR, AST, total leucocyte count ranging from minimum score of 0 till maximum of 20 with a higher score correlating with a worse outcome. A score of NWI \>=11 is associated with increased mortality and considered an indication for consideration for liver transplantation in patients with Wilson disease.
Time frame: 7 days
Comparison of change in serum and urine copper levels on day 7 after initiation of plasmapheresis as compared to baseline in alternate versus daily plasma exchange group.
Time frame: Day 7
Comparison of overall and native liver survival at day 90 between the two groups
Time frame: 90 days
Comparison of change in dialysate copper levels at the end of 3rd session between both groups.
Time frame: 1 week
Comparison of total number of sessions of plasma exchange between both groups as on day 28.
Time frame: Day 28
Comparison of AST in U/L, ALT in U/L at end of 3rd plasma exchange compared to baseline.
Time frame: 1 week
Comparison of corrected reticulocyte count (percentage) at end of 3rd plasma exchange compared to baseline.
Time frame: 1 week
Comparison of International Normalised Ratio (INR) at end of 3rd plasma exchange compared to baseline.
Time frame: 1 week
Comparison of bilirubin (mg/dL) at end of 3rd plasma exchange compared to baseline.
Time frame: 1 week
Comparison of albumin (mg/dL) at end of 3rd plasma exchange compared to baseline.
Time frame: 1 week
Comparison of serious adverse events as defined by CTCAE criteria in both the groups.
Time frame: 90 days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Dec 2026, 25 months later.
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