Phase 3 N=37 Treatment

Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.

Wilson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00212355 ↗

Enrolled (actual)

Serious AEs

10.8%

Results posted

May 2014

Primary outcome: Primary: Safety and Efficacy — 37 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: NPC-02 (Drug)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Nobelpharma
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Efficacy	37	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Wilson's disease(adult, infant, pregnant woman)

Exclusion Criteria

Acute hepatitis
Malignant tumor

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00212355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.