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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-02 | Experimental | zinc acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-02 | Drug | zinc acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Efficacy | Number of patients who have at least one adverse events. ALT Change | During study period (up to 96W ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koudou Ishii, M.D. | National MINAMIYOKOHAMA Hospital | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21078496 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NPC-02 | zinc acetate NPC-02: zinc acetate |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed subjects comprised 37 patients who were found to have Wilson disease through clnical and biochemical tests.
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| ID | Title | Description |
|---|---|---|
| BG000 | NPC-02 | zinc acetate NPC-02: zinc acetate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Efficacy | Number of patients who have at least one adverse events. ALT Change | The analysis was performed based on FAS population | Posted | Number | participants | During study period (up to 96W ) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NPC-02 | zinc acetate NPC-02: zinc acetate |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA-J 9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA-J 9.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department director of clinical development department 1 | Nobelpharama | +81-3-5651-1177 | murakami@nobelpharma.co.jp |
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| ID | Term |
|---|---|
| D006527 | Hepatolenticular Degeneration |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
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| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 4 |
| 37 |
| 37 |
| 37 |
| Colitis ulcerative | Immune system disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Sebaceous naevus | Congenital, familial and genetic disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Myopia | Eye disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Pain chest | General disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Acute bronchitis | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Molluscum contagious | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Otitis meda | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Bruise | Injury, poisoning and procedural complications | MedDRA-J 9.0 | Non-systematic Assessment |
|
| ALT increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| AST increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Blood alubumin decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Cholesterol blood decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Mean cell haemoglobin concentration decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Mean corpuscular volume decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Urobilin urine present | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| ALP increased | Investigations | MedDRA-J 9.0 | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA-J 9.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA-J9.0 | Non-systematic Assessment |
|
There is an agreement between the sponsor and PI that no restricts the PI's right but need to discuss the timing of publish date of trial results after the trial is completed.
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D008664 | Metal Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |