Decompensation of Cirrhosis and Iron Metabolism | NCT04807023

Studies
Decompensation of Cirrhosis and Iron Metabolism

NCT04807023

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jun 12, 2026Actual

Enrollment

98Actual

Phase

Not provided

Conditions

Cirrhosis

Interventions

blood sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A02454-35	Other Identifier	N° IDRCB

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2021Actual

Primary Completion Date

Sep 20, 2024Actual

Completion Date

Sep 20, 2025Actual

First Submitted Date

Mar 16, 2021

First Submission Date that Met QC Criteria

Mar 16, 2021

First Posted Date

Mar 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified.

A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality.

Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Name	Type	Description	Arm Group Labels	Other Names
blood sampling	Biological	blood sampling

Measure	Description	Time Frame
Mortality		day 28

Measure	Description	Time Frame
Serum levels of abnormal iron		days 0, 2, 7 and 14
Ceruloplasmin ferroxidase activity		days 0, 2, 7 and 14
hepcidin blood levels

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old.
Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
Hospitalization for acute on chronic liver failure:
Ascites decompensation.
Or spontaneous infection of the ascites fluid (defined as PNN > 250/mm3 of ascites).
Or digestive hemorrhage related to portal hypertension (digestive fibroscopy showing active bleeding or stigmas of recent bleeding from esophageal and/or gastric varices).
Or hepatic encephalopathy (clinically defined +/- increase in ammonia and/or by electroencephalogram and classified in stages according to West-Haven).
Or hepato-renal syndrome (HRS-AKI criteria, EASL 2018).
Or bacterial infection (defined by a bacteremia identified by at least one blood culture and/or an infectious site authenticated on imaging).
Or Acute Alcoholic Hepatitis (histologically proven or not).
Non-opposition of the patient, relative or legal representative.

Exclusion Criteria:

Treatment with oral or intravenous iron in the month prior to hospitalization.
Implementation of a TIPS in the month prior to admission.
Presence of hepatocellular carcinoma with an expected survival < 3 months or any other progressive cancer.
Adult person subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with diagnosis of cirrhosis hospitalized for acute on chronic liver failure

Sampling Method

Non-Probability Sample

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis