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COMPARISON OF ZINC ACETATE DOSE REGIMENS (GALZIN VS. ET-700) FOR THE TREATMENT OF WILSON DISEASE: A PHARMACODYNAMIC 64CUCL2 PET/CT STUDY IN HEALTHY PARTICIPANTS

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523372-24-00
Enrollment
36
Registered
2026-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wilson's Disease

Brief summary

The primary endpoint is the change in mean hepatic 64Cu standard uptake value (SUV) from pre- to post-intervention between the three groups.

Detailed description

Change in plasma zinc, total copper, exchangeable copper, and ceruloplasmin levels from pre- to post-intervention between the groups., Change in metallothionein (a protein related to homeostasis of e.g. zinc and copper) induction in peripheral blood mononuclear cells from pre- to post-intervention between the groups., Change in urinary zinc and copper levels from pre- to post-intervention between the groups., Number of AEs in the three groups.

Interventions

DRUGGalzin 50mg
DRUGET-700 75 mg
DRUGPlacebo
DRUGCOPPER (64CU) CHLORIDE

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the change in mean hepatic 64Cu standard uptake value (SUV) from pre- to post-intervention between the three groups.

Secondary

MeasureTime frame
Change in plasma zinc, total copper, exchangeable copper, and ceruloplasmin levels from pre- to post-intervention between the groups., Change in metallothionein (a protein related to homeostasis of e.g. zinc and copper) induction in peripheral blood mononuclear cells from pre- to post-intervention between the groups., Change in urinary zinc and copper levels from pre- to post-intervention between the groups., Number of AEs in the three groups.

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 3, 2026