Pyrophosphate Homeostasis and Hepatic Expression of ABCC6.Pyro-TH (Pyro-TH)
Primary Purpose
Hepatic Failure
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Hepatic Failure
Eligibility Criteria
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
Sites / Locations
- Untiversity Hospital of NiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
cirrhotic patients with chronic liver failure
cirrhotic patients without chronic liver failure
Arm Description
Outcomes
Primary Outcome Measures
plasma PPi concentration between before transplantation and liver function restoration in the both arms
Secondary Outcome Measures
Full Information
NCT ID
NCT03576859
First Posted
June 22, 2018
Last Updated
November 20, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03576859
Brief Title
Pyrophosphate Homeostasis and Hepatic Expression of ABCC6.Pyro-TH
Acronym
Pyro-TH
Official Title
Pyrophosphate Homeostasis and Hepatic Expression of ABCC6. Pilot Study in Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
November 6, 2020 (Anticipated)
Study Completion Date
November 6, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cirrhotic patients with chronic liver failure
Arm Type
Other
Arm Title
cirrhotic patients without chronic liver failure
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
Peripheral venous blood is collected before liver transplantation and after restoration of liver function
Primary Outcome Measure Information:
Title
plasma PPi concentration between before transplantation and liver function restoration in the both arms
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio IANNELLI, PHD
Phone
33 492 03 60 44
Email
iannelli.a@chu-nice.fr
Facility Information:
Facility Name
Untiversity Hospital of Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio IANNELLI, PHD
Phone
33 4 92 03 40 66
Email
iannelli.a@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Guillaume FAVRE, MCUPH
Phone
33 4 92 03 84 28
Email
favre.g@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pyrophosphate Homeostasis and Hepatic Expression of ABCC6.Pyro-TH
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