- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03589820
Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure
July 17, 2018 updated by: Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
Clinical Efficacy of Artificial Liver Support System Using Combination of Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease - Related Liver Failure
This study is to investigate the clinical efficacy of artificial liver support system using combination of plasma exchange and continuous hemodiafiltration in treatment of Wilson's Disease - related liver failure.
30 patients will receive treatment of plasma exchange and continuous hemodiafiltration and internal medicine.
30 patients will receive treatment of internal medicine.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Wilson's disease (WD) is an inherited disorder in which defective biliary excretion of copper leads to its accumulation, particularly in liver and brain.
Presenting symptoms of liver disease can be highly variable, ranging from asymptomatic, with only biochemical abnormalities, to overt cirrhosis with all its complications.
Acute liver failure (ALF) presentation is the most dramatic and may arise with catastrophic suddenness.
It is considered rare, constituting only 3% of ALF cases in the pediatric ALF series in USA and associated with a high mortality reaching 95%.
Patients with acute liver failure due to WD require liver transplantation, which is lifesaving.
Kido J et al reported clinical outcomes of patients with liver failure were improved by artificial liver support system using combination of plasma exchange and continuous hemodiafiltration.
So the investigators design this protocol: 30 patients will receive treatment of plasma exchange and continuous hemodiafiltration and internal medicine, 30 patients will receive treatment of internal medicine.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510630
- The Third Affiliated Hospital of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of Wilson Disease: serum ceruloplasmin < 0.2g/L, 24 hours urinary copper > 40μg, Kayser-Fleischer ring present;
- Do not receive drugs to promote the excretion of copper ever before;
- Serum total bilirubin > 10 times upper limit of normal, prothrombin time activity < 40% or prothrombin time international ratio > 1.5.
Exclusion Criteria:
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
- Other important organ dysfunctions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Artificial liver support system group
30 patients will receive treatment of artificial liver support system using combination of plasma exchange and continuous hemodiafiltration and internal medicine.
|
Patients will receive the treatment of artificial liver support system using combination of plasma exchange and continuous hemodiafiltration and internal medicine.
The volume of fresh frozen plasma used in plasma exchange is 2000 millilitre.
The time for continuous hemodiafiltration is about 8 hours.
|
No Intervention: Control group
30 patients will receive treatment of internal medicine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival rate
Time Frame: 48 weeks
|
Whether patients will survive is observed in the follow-up.
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
liver function improvement
Time Frame: 48 weeks
|
Symptoms (i.e.
fatigue, appetite, nausea, vomiting, jaundice, consciousness) and laboratory tests (i.e.
blood cells, alanine transaminase, total bilirubin, prothrombin time, creatinine, ceruloplasmin, serum copper) are observed in the follow-up.
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Anticipated)
June 28, 2020
Study Completion (Anticipated)
July 31, 2020
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
July 17, 2018
First Posted (Actual)
July 18, 2018
Study Record Updates
Last Update Posted (Actual)
July 18, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Liver Diseases
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Metabolism, Inborn Errors
- Heredodegenerative Disorders, Nervous System
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Metal Metabolism, Inborn Errors
- Liver Failure
- Hepatic Insufficiency
- Hepatolenticular Degeneration
Other Study ID Numbers
- XWX1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Failure
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Beijing Continent Pharmaceutical Co, Ltd.RecruitingAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
HLB Cell Co., Ltd.UnknownAcute-On-Chronic Liver Failure | Acute Liver FailureKorea, Republic of
-
Tianjin Weikai Bioeng., Ltd.Tianjin Nankai HospitalUnknownLiver Failure, Acute on ChronicChina
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver Failure | Acute on Chronic Liver FailureIndia
-
Nanfang Hospital of Southern Medical UniversityCompletedLiver Injury | Liver Failure, Acute on Chronic
-
Third Affiliated Hospital, Sun Yat-Sen UniversityWithdrawnLiver Failure, Acute on ChronicChina
-
Third Affiliated Hospital, Sun Yat-Sen UniversityWithdrawnAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
RenJi HospitalNot yet recruiting
-
RenJi HospitalShanghai Institute of Biochemistry and Cell BiologyNot yet recruitingAcute-On-Chronic Liver Failure | Chronic Liver Failure
Clinical Trials on artificial liver support system
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingAcute-On-Chronic Liver Failure | Hepatitis B, ChronicChina
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingAcute-On-Chronic Liver Failure | Hepatitis B, Chronic | ThrombocytopeniaChina
-
Vital Therapies, Inc.TerminatedAcute Liver Failure | Fulminant Hepatic Failure | Primary Graft Non-Function | Surgically-Induced Liver FailureUnited States
-
Vital Therapies, Inc.TerminatedSevere Acute Alcoholic HepatitisUnited States, Spain, United Kingdom, Germany
-
Technische Universität DresdenRecruitingInvasive Mechanical VentilationSwitzerland, Germany, Spain, United States, Serbia
-
University Hospital FreiburgUnknown
-
Qin NingRecruitingTo Evaluate the Clinical Efficacy and Safety of the New ALSSChina
-
Centre hospitalier de l'Université de Montréal...Withdrawn
-
Shanghai East HospitalChinese Academy of SciencesUnknown
-
National Taiwan University HospitalUnknownLiver Failure | Critical CareTaiwan