Phlebotomy and Risk of Hepatocellular Carcinoma in Patients With Compensated Alcoholic Cirrhosis (NCT01342705) | Clinical Trial Compass
TerminatedPhase 3
Phlebotomy and Risk of Hepatocellular Carcinoma in Patients With Compensated Alcoholic Cirrhosis
Stopped: delayed recruitment as compared to that expected
France17 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* Complication of cirrhosis at time of inclusion (defined as bleeding related to portal hypertension, encephalopathy or ascites)
* Presence of hepatitis B or hepatitis C co-infection
* Presence of liver focal lesion suggestive of HCC
* Child-Pugh score greater than or equal to 7 (Class B or C) at time of inclusion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence of HepatoCellular Carcinoma during follow-up