NCT01342705

Brief Summary

The main objective of the study is to assess in patients with compensated alcoholic cirrhosis and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in order to lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular carcinoma (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1) episodes of hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO during follow-up.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2011

Typical duration for phase_3

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 21, 2015

Status Verified

November 1, 2012

Enrollment Period

3.1 years

First QC Date

April 14, 2011

Last Update Submit

April 20, 2015

Conditions

Alcoholic CirrhosisIron Overload

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of HepatoCellular Carcinoma during follow-up

    the cumulative incidence of HCC will be estimated considering death prior to the event of interest as competing risk outcomes

    3 years

Secondary Outcomes (3)

  • Number of hepatic decompensation episodes in study participants

    3 years

  • Cumulative incidence of death non related to hepatoCellular Carcinoma

    3 years

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    3 years

Study Arms (2)

phlebotomy

EXPERIMENTAL
Procedure: phlebotomy

control

NO INTERVENTION

Interventions

phlebotomyPROCEDURE

Procedure: Phlebotomy of 4 ml / kg to obtain (1 phlebotomy every 14 days) and maintain (1 phlebotomy every 3 months) a serum ferritin below 50 µg / l.

Also known as: Bloodletting, Iron depletion
phlebotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Biopsy-proven alcoholic cirrhosis
  • No previous HCC (treated or not)
  • Excessive alcohol consumption, defined by more than 21 glasses weekly in women and more than 28 glasses weekly in men for at least 10 years, and considered as the main cause for liver cirrhosis
  • Signed written informed consent
  • Hepatic iron overload assessed by MRI (Iron hepatic concentration ≥ 80 μmol/g)

You may not qualify if:

  • Subjects deprived of their liberty by judicial or administrative decision
  • Pregnant women
  • Serious associated short-term life threatening disease (except HIV viral co-infection, or the liver disease itself)
  • Impossibility of monitoring, whatever the reason.
  • Contraindication of phlebotomy
  • Haemoglobin \<13.5 g/dL for men and \<12.5g/dL for women (threshold established by the French Blood Agency)
  • Congestive heart failure or coronary heart disease
  • Hepatic failure (TP\<60%), renal failure (GFR \<50 ml/min) or respiratory insufficiency (chronic dyspnea)
  • Poor venous system
  • Presence of hepatitis B or hepatitis C co-infection
  • Presence of liver focal lesion suggestive of HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Amiens University Hospital :

Amiens, France

Location

Avicenne

Bobigny, France

Location

Jean Verdier

Bondy, 93140, France

Location

CHU Bordeaux univerity hospital 1

Bordeaux, France

Location

CHU Bordeaux University hospital 2

Bordeaux, France

Location

CHU

Caen, France

Location

Antoine Béclère

Clamart, France

Location

CHU

Grenoble, France

Location

CHU

Lille, France

Location

CHU

Montpellier, France

Location

CHU

Nancy, France

Location

CHU

Nice, France

Location

CHU

Rennes, France

Location

CHU

Rouen, France

Location

MeSH Terms

Conditions

Liver Cirrhosis, AlcoholicIron Overload

Interventions

PhlebotomyBloodletting

Condition Hierarchy (Ancestors)

Liver CirrhosisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre NAHON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 27, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 21, 2015

Record last verified: 2012-11

Locations

FR(14)