Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07465718
Eligibility Criteria:
Inclusion Criteria:
1. Participant is aged 8 years or older and is willing and able to give informed consent for participation in the study, or by a parent/legally authorized representative (LAR) and assent obtained (in accordance with local regulations) for any participant less than the age of majority (e.g. less than 18 years of age, depending on local requirements).
2. Participant has a body weight of at least 25 kg at screening.
3. Participant has a diagnosis of WD, as defined by a Leipzig score of greater than or equal to 4. Note that historical test results can be used for the diagnosis.
4. Participant has either:
1. Received no prior prescribed therapy \[a\] for the treatment of WD (treatment-naïve), or
2. Received no prescribed chelator therapy \[a\] for the treatment of WD (chelator-naïve); zinc salts are permitted for no more than 28 days prior to the start of screening assessments, and these participants must be symptomatic.
\[a\] prescribed therapy for WD refers to the authorized chelator treatments of trientine (TETA 2HCl or TETA 4HCl) and DPA, or zinc salts.
5. Able and willing to comply with study procedures and requirements, as described in the informed consent.
6. Adequate venous access to allow collection of required blood samples.
7. Willing to comply with low copper diet for the duration of the study.
8. Participant requires treatment for WD, in the opinion of the Investigator.
9. Participant is able to take the study medication as prescribed, in the opinion of the Investigator.
Exclusion Criteria:
1. Any known contraindications for treatment with DPA.
2. Any known contraindications for treatment with TETA 4HCl.
3. Unable to swallow tablets/capsules independently or considered high risk for aspiration, in the opinion of the Investigator
4. Acute liver failure (ALF) or at high risk of ALF, in the opinion of the Investigator.
5. Decompensated hepatic cirrhosis, in the opinion of the Investigator.
6. Participants 12 years or older at screening, Model for End stage Liver Disease (MELD) score of greater than or equal to 12.
7. Participants 8 to 11 years at screening, Model for Pediatric End stage Liver Disease (PELD) of greater than or equal to 10
8. Hemoglobin of less than or equal to 9 g/dL.
9. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m²
10. Nephritis or nephrotic syndrome, in the opinion of the Investigator.
11. Alanine aminotransferase greater than 5 times upper limit of normal (ULN).
12. Severe pulmonary disease requiring home nebulization and/or home oxygen therapy.
13. Clinically significant gastrointestinal bleed within past 6-months.
14. Neurological disease requiring either nasogastric feeding or intensive inpatient medical care.
15. Active or history of seizures requiring anti-epileptics within 6 months prior to informed consent.
16. Active infection with hepatitis B virus (positive hepatitis B surface antigen) or C virus or seropositivity for human immunodeficiency virus (HIV).
17. Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the collection or interpretation of the study results.
18. Female participants of childbearing potential, currently pregnant, currently nursing, or planning a pregnancy during study period.
19. Female participants of childbearing potential, unable or unwilling to use a reliable form of contraceptive throughout the study.
20. Male participants, unable or unwilling to use a reliable form of contraceptive throughout the study.
21. Participant is not willing to comply with the prohibited medication requirements for the study.
22. In the opinion of the Investigator, the participant is likely to be non-compliant or uncooperative for the required study visits or study assessments, or has any disease, disability, illness or abnormal laboratory values that could compromise patient safety or interfere with the collection or interpretation of study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT07465718
Study Brief:
Protocol Section:
NCT07465718