NCT00212355

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2005

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2014

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3.1 years

First QC Date

September 13, 2005

Results QC Date

April 9, 2014

Last Update Submit

February 18, 2025

Conditions

Wilson's Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and Efficacy

    Number of patients who have at least one adverse events. ALT Change

    During study period (up to 96W )

Study Arms (1)

NPC-02

EXPERIMENTAL

zinc acetate

Drug: NPC-02

Interventions

NPC-02DRUG

zinc acetate

NPC-02

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute hepatitis
  • Malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shimizu N, Fujiwara J, Ohnishi S, Sato M, Kodama H, Kohsaka T, Inui A, Fujisawa T, Tamai H, Ida S, Itoh S, Ito M, Horiike N, Harada M, Yoshino M, Aoki T. Effects of long-term zinc treatment in Japanese patients with Wilson disease: efficacy, stability, and copper metabolism. Transl Res. 2010 Dec;156(6):350-7. doi: 10.1016/j.trsl.2010.08.007. Epub 2010 Sep 23.

    PMID: 21078496RESULT

MeSH Terms

Conditions

Hepatolenticular Degeneration

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsMetal Metabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Department director of clinical development department 1
Organization
Nobelpharama
murakami@nobelpharma.co.jp
+81-3-5651-1177

Study Officials

  • Koudou Ishii, M.D.

    National MINAMIYOKOHAMA Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2005

Primary Completion

April 1, 2008

Study Completion

January 1, 2009

Last Updated

March 5, 2025

Results First Posted

May 14, 2014

Record last verified: 2025-02