Examining copper levels in breast milk of pregnant women with Wilson's disease
Official title: Description of the Copper Concentration in Breast Milk in Women Treated for Wilson's Disease
Run by Fondation Ophtalmologique Adolphe de Rothschild · NCT05183165 · Data updated 2026-11-12
This study tests how treatment for Wilson's disease affects copper levels in the breast milk of pregnant women to ensure the health of both mom and baby during breastfeeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | May 11, 2022 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT05183165 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 and older who have been diagnosed with Wilson's disease.
✕Probably not a fit
Patients who have undergone a liver transplant or cannot provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the concentration of copper in breast milk from women diagnosed with Wilson's disease who are currently pregnant. Wilson's disease is a genetic disorder that leads to copper accumulation in the body, and this research aims to understand how treatment during pregnancy affects copper levels in breast milk. Participants will include women over 18 years old who meet specific criteria related to Wilson's disease and pregnancy. The study will monitor copper levels to ensure the health of both mother and child during breastfeeding.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of breastfeeding for mothers with Wilson's disease and their infants.
How similar studies have gone: While studies on copper metabolism in Wilson's disease exist, this specific focus on breast milk during pregnancy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Criteria for inclusion : * Patient aged 18 years or over. * Wilson's disease fulfilling the criteria for the Leipzig score * Pregnancy in progress whatever the term. * Express consent to participate in the study. * Affiliate or beneficiary of a social security system. Criteria for non-inclusion : * Liver transplant patient * No affiliation to Social Security system * VuInability to give free and informed consent * Patient benefiting from a legal protection measure
Where it's running
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Fondation Adolphe de Rothschild
Paris, France Recruiting
Study contacts
- Study coordinator: Amélie YAVCHITZ
- Email: ayavhitz@for.paris
- Phone: 01 48 03 64 54
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PM577a: a one-time gene-editing therapy for Wilson disease
This study tests PM577a, a gene-editing treatment, to see if it is safe and may help people with Wilson disease who have a p.H1069Q ATP7B mutation.
-
One-a-day trientine for newly diagnosed Wilson's disease
A new once-daily trientine formulation is being tested against d-Penicillamine as a first-line treatment for people with Wilson's disease, including both children 8 and older and adults.
-
ATP7B mRNA (DSL101) therapy for Wilson disease
This treatment will test whether one or more IV infusions of ATP7B mRNA (DSL101) are safe and help control copper in adults with genetically confirmed Wilson disease.
-
Investigating heart issues in Wilson's Disease
This study is testing how Wilson's Disease affects the heart in adults by using long-term heart monitoring to see if copper buildup causes any problems.
-
International registry for Wilson's Disease patients
This study is gathering information from people with Wilson's Disease during their regular doctor visits to better understand the disease and how patients are managing it.
-
Observational study on Wilson's Disease
This study looks at how Wilson's Disease affects people in different ways to help improve care for patients and their families.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.