Copper supplementation for people with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional trial giving oral copper (copper gluconate) to adults with confirmed cirrhosis who have low serum/plasma copper or clinical features suggestive of copper deficiency. Participants will be treated and followed at the University of Washington Medical Center with serial blood tests and clinical monitoring for liver function, nutritional status, and infection-related outcomes. Patients with conditions associated with copper overload (for example Wilson disease or cholestatic liver diseases) or with fulminant hepatic failure are excluded. The approach is based on prior observational work and small case reports suggesting copper deficiency is common in liver disease and may be reversible with supplementation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients age 18 or older with confirmed diagnosis of cirrhosis based on clinical history, exam, imaging, laboratory or histological criteria;
2. Cirrhosis patients whose serum or plasma Cu are below the normal range (80-155 ug/dL for women and 70-140 ug/dL for men);
3. Cirrhosis patients whose serum or plasma Cu are in the normal range but exhibit at least one clinical feature that has been associated with Cu deficiency. These include history of infections, unexplained anemia, severe leukopenia, iron overload, unexplained neurological symptoms such as ataxia or myelopathy, coagulopathy with spontaneous bleeding.

Patients must meet inclusion criteria 1 AND 2, or 1 AND 3 in order to be considered for the trial

Exclusion Criteria:

1. Patients with Wilson disease, cholestatic liver diseases including primary biliary cholangitis and primary sclerosing cholangitis, all of which are associated with Cu overload;
2. Patients with fulminant hepatic failure;
3. Renal failure with a creatinine clearance \<25 ml/minute;
4. Hepatic encephalopathy more than grade 2 (Hepatic Encephalopathy in Chronic Liver Disease, 2014);
5. MELD score \>25 to minimize subject dropout due to been too ill;
6. Serious non-liver related medical illnesses such as cardiopulmonary and renal diseases and non-liver malignancies;
7. Active alcohol use;
8. Pregnancy

Where it's running

• University of Washington Medical Center
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Lei Yu, MD — University of Washington
• Study coordinator: Laura Sissons-Ross
• Email: lsissons@uw.edu
• Phone: 206-616-0397

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.