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NCT06698991
Daily Versus Alternate Day Plasma Exchange in Wilson Disease With Acute Liver Failure in Children
NA trial testing Plasma Exchange in Acute Liver Failure in 20 participants. Not yet recruiting.
31 December 2026
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 | 20 |
| Start date | 10 November 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across India |
Drugs / interventions tested
- Plasma Exchange — full drug profile →
- Standard Medical Treatment — full drug profile →
Conditions studied
- Acute Liver Failure — all drugs for Acute Liver Failure →
- Wilson Disease — all drugs for Wilson Disease →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 3 to 18, any sex, with Acute Liver Failure or Wilson Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06698991
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Plasma Exchange
Trials testing the same drug.
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- 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 Acute Liver Failure
Currently open trials in the same condition.
- NCT06831643 — Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure · NA · recruiting
- NCT06872372 — Role of N-Acetylcysteine in Non-Acetaminophen-Induced Acute Liver Failure · NA · active not recruiting
- NCT07329036 — ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of · NA · recruiting
- NCT05689645 — F573 for Injection for the Treatment of Liver Injury/Failure · Phase 2 · recruiting
- NCT05413083 — Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis · 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
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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 NCT06698991 (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: 21 November 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing