Pyrophosphate Homeostasis and Hepatic Expression of ABCC6.Pyro-TH

Hepatic Failure Clinical Trial

— Pyro-TH  

Official title:

Pyrophosphate Homeostasis and Hepatic Expression of ABCC6. Pilot Study in Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576859
• Other study ID #: 18-AOI-11
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: October 29, 2020

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In animals, normal hepatic expression of ABCC6 (ATP-binding transporter cassette, subfamily C, member 6) determines plasma pyrophosphate (PPi) concentration. PPi prevents the formation of hydroxyapatite crystals on tissues by precipitation of calcium and inorganic phosphate (Pi). It is an endogenous compound whose deficiency causes diffuse vascular calcifications in certain rare monogenic diseases, including the elastic pseudoxanthoma caused by the mutation of ABCC6. PPi is produced by enzymatic transformation of extracellular ATP and, in animals, the liver is the main supplier of ATP and PPi (more than 90%). In humans, liver transplantation offers the possibility of correlating the plasma concentration of PPi ([PPi]pl) with hepatic expression of ABCC6. Liver transplantation is performed in the treatment of chronic liver failure (Child B or C) or, in the absence of liver failure, in the treatment of hepatocellular carcinoma. By measuring[PPi]pl before transplantation and after liver function restoration and by measuring ABCC6 in the diseased liver and healthy liver, it is possible to determine whether liver failure is associated with decreased[PPi]pl and decreased liver expression of ABCC6, which is the objective of our pilot study. Its interest is to establish a physiopathological link between the frequent vascular calcifications in obese patients with hepatic steatosis and the production of PPi.

prupose: Look for a deficit in[PPi]pl in patients before the transplant compared to the phase of restoration of liver function

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Indication for liver transplantation Age greater than or equal to 18 years Patients affiliated to social security

Exclusion Criteria:

Patient not affiliated to social security Non-consenting patient or unable to understand the protocol and how it works Fulminant Hepatitis

Related Conditions & MeSH terms

• Hepatic Failure
• Hepatic Insufficiency
• Liver Failure

Intervention

Other:
• blood sample
Peripheral venous blood is collected before liver transplantation and after restoration of liver function

Locations

Country	Name	City	State
France	Untiversity Hospital of Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma PPi concentration between before transplantation and liver function restoration in the both arms		24 months