A Phase 3 interventional study of NPC-02 in Wilson's Disease, sponsored by Nobelpharma. Completed. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Nobelpharma · Phase 3, Interventional, and Treatment
The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.
Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the use of copper chelating agents, such as D-penicillamine and trientine. In this study, we investigate efficacy on zinc acetate in Japanese patients with Wilson disease.
78 studies on the registry are indexed under Hepatolenticular Degeneration; 30 are open to participants now.
This study's enrollment of 37 is above the median of 30 across 42 interventional studies indexed under Hepatolenticular Degeneration.
Browse Hepatolenticular Degeneration studies →Nobelpharma is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
zinc acetate
Drug: NPC-02
zinc acetate
Safety and Efficacy
Number of patients who have at least one adverse events. ALT Change
Time frame: During study period (up to 96W )
| Milestone | NPC-02 |
|---|---|
| Started | 37 |
| Completed | 34 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: A change of address | 1 |
Number of patients who have at least one adverse events. ALT Change
| participants | NPC-02 |
|---|---|
| Safety and Efficacy | 37 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NPC-02 | — | 4/37 (10.8%) | 37/37 (100%) |
| Event | NPC-02 |
|---|---|
| DepressionPsychiatric disorders | 1/37 |
| Colitis ulcerativeImmune system disorders | 1/37 |
| VaricellaInfections and infestations | 1/37 |
| Sebaceous naevusCongenital, familial and genetic disorders | 1/37 |
| Event | NPC-02 |
|---|---|
| Lipase increasedInvestigations | 28/37 |
| NasopharyngitisInfections and infestations | 24/37 |
| Blood iron decreasedInvestigations | 22/37 |
| Blood amylase increasedInvestigations | 21/37 |
| Blood urine presentInvestigations | 14/37 |
| Protein urine presentInvestigations | 13/37 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 13/37 |
| Blood triglycerides increasedInvestigations | 12/37 |
| InfluenzaInfections and infestations | 9/37 |
| Stomach discomfortGastrointestinal disorders | 7/37 |
Analysis was performed subjects comprised 37 patients who were found to have Wilson disease through clnical and biochemical tests.
| Age, Customized(participants) | NPC-02 |
|---|---|
| ≥16 | 20 |
| ≥6 - <16 | 15 |
| ≥1 - <6 | 2 |
| Sex: Female, Male(Participants) | NPC-02 |
|---|---|
| Female | 24 |
| Male | 13 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Hepatolenticular Degeneration→
Nobelpharma