Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure
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|ClinicalTrials.gov Identifier: NCT03589820|
Recruitment Status : Enrolling by invitation
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Wilson Disease Liver Failure||Other: artificial liver support system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Efficacy of Artificial Liver Support System Using Combination of Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease - Related Liver Failure|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 28, 2020|
|Estimated Study Completion Date :||July 31, 2020|
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.
Other: artificial liver support system
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.
- survival rate [ Time Frame: 48 weeks ]Whether patients will survive is observed in the follow-up.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589820
|The Third Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510630|
|Principal Investigator:||Liang Peng, Doctor||Third Affiliated Hospital, Sun Yat-Sen University|