Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure

NCT03589820 | Unknown DMC

• 1 other identifier: XWX1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wilson Disease; Liver Failure

Keywords

Wilson Disease; Liver Failure; plasma exchange; continuous hemodiafiltration

Outcome Measures

Primary Outcomes (1)

• survival rate

  Whether patients will survive is observed in the follow-up.

  48 weeks

Secondary Outcomes (1)

• liver function improvement

  48 weeks

Study Arms (2)

Artificial liver support system group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

30 patients will receive treatment of internal medicine.

Interventions

artificial liver support system OTHER

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.

Artificial liver support system group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Hepatolenticular Degeneration; Liver Failure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Hepatic Insufficiency

Study Officials

• Liang Peng, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 18, 2018
• Study Start: June 1, 2018
• Primary Completion: June 28, 2020
• Study Completion: July 31, 2020
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CN (1)