Trial Outcomes & Findings for Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan. (NCT NCT00212355)
NCT ID: NCT00212355
Last Updated: 2025-03-05
Results Overview
Number of patients who have at least one adverse events. ALT Change
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
37 participants
Primary outcome timeframe
During study period (up to 96W )
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
NPC-02
zinc acetate
NPC-02: zinc acetate
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
NPC-02
zinc acetate
NPC-02: zinc acetate
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
A change of address
|
1
|
Baseline Characteristics
Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Baseline characteristics by cohort
| Measure |
NPC-02
n=37 Participants
zinc acetate
NPC-02: zinc acetate
|
|---|---|
|
Age, Customized
≥16
|
20 participants
n=5 Participants
|
|
Age, Customized
≥6 - <16
|
15 participants
n=5 Participants
|
|
Age, Customized
≥1 - <6
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During study period (up to 96W )Population: The analysis was performed based on FAS population
Number of patients who have at least one adverse events. ALT Change
Outcome measures
| Measure |
NPC-02
n=37 Participants
zinc acetate
NPC-02: zinc acetate
|
|---|---|
|
Safety and Efficacy
|
37 participants
|
Adverse Events
NPC-02
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NPC-02
n=37 participants at risk
zinc acetate
NPC-02: zinc acetate
|
|---|---|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1
|
|
Immune system disorders
Colitis ulcerative
|
2.7%
1/37 • Number of events 2
|
|
Infections and infestations
Varicella
|
2.7%
1/37 • Number of events 1
|
|
Congenital, familial and genetic disorders
Sebaceous naevus
|
2.7%
1/37 • Number of events 1
|
Other adverse events
| Measure |
NPC-02
n=37 participants at risk
zinc acetate
NPC-02: zinc acetate
|
|---|---|
|
Eye disorders
Conjunctivitis allergic
|
5.4%
2/37 • Number of events 2
|
|
Eye disorders
Myopia
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
8.1%
3/37 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.2%
6/37 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
16.2%
6/37 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
16.2%
6/37 • Number of events 6
|
|
Gastrointestinal disorders
Stomach discomfort
|
18.9%
7/37 • Number of events 9
|
|
Gastrointestinal disorders
Stomatitis
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Pain chest
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Edema peripheral
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Fever
|
13.5%
5/37 • Number of events 5
|
|
Immune system disorders
Seasonal allergy
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Acute bronchitis
|
10.8%
4/37 • Number of events 5
|
|
Infections and infestations
Gastroenteritis
|
10.8%
4/37 • Number of events 5
|
|
Infections and infestations
Hordeolum
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Influenza
|
24.3%
9/37 • Number of events 9
|
|
Infections and infestations
Molluscum contagious
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
64.9%
24/37 • Number of events 43
|
|
Infections and infestations
Otitis meda
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
18.9%
7/37 • Number of events 7
|
|
Infections and infestations
Rhinitis
|
8.1%
3/37 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
8.1%
3/37 • Number of events 3
|
|
Infections and infestations
Varicella
|
5.4%
2/37 • Number of events 2
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.4%
2/37 • Number of events 2
|
|
Injury, poisoning and procedural complications
Bruise
|
5.4%
2/37 • Number of events 2
|
|
Investigations
ALT increased
|
16.2%
6/37 • Number of events 6
|
|
Investigations
AST increased
|
8.1%
3/37 • Number of events 3
|
|
Investigations
Blood alubumin decreased
|
5.4%
2/37 • Number of events 2
|
|
Investigations
Blood amylase increased
|
56.8%
21/37 • Number of events 23
|
|
Investigations
Blood bilirubin increased
|
10.8%
4/37 • Number of events 4
|
|
Investigations
Cholesterol blood decreased
|
16.2%
6/37 • Number of events 6
|
|
Investigations
Blood iron decreased
|
59.5%
22/37 • Number of events 25
|
|
Investigations
Blood triglycerides increased
|
32.4%
12/37 • Number of events 14
|
|
Investigations
Haematocrit decreased
|
8.1%
3/37 • Number of events 3
|
|
Investigations
Blood urine present
|
37.8%
14/37 • Number of events 15
|
|
Investigations
Hemoglobin decreased
|
10.8%
4/37 • Number of events 4
|
|
Investigations
Lipase increased
|
75.7%
28/37 • Number of events 29
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
10.8%
4/37 • Number of events 4
|
|
Investigations
Mean corpuscular volume decreased
|
8.1%
3/37 • Number of events 3
|
|
Investigations
Platelet count decreased
|
5.4%
2/37 • Number of events 3
|
|
Investigations
Protein total decreased
|
5.4%
2/37 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
18.9%
7/37 • Number of events 7
|
|
Investigations
White blood cell count increased
|
13.5%
5/37 • Number of events 5
|
|
Investigations
Platelet count increased
|
8.1%
3/37 • Number of events 3
|
|
Investigations
Protein urine present
|
35.1%
13/37 • Number of events 16
|
|
Investigations
Urobilin urine present
|
5.4%
2/37 • Number of events 2
|
|
Investigations
ALP increased
|
10.8%
4/37 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
5.4%
2/37 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.2%
6/37 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
2/37 • Number of events 2
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • Number of events 4
|
|
Nervous system disorders
Hypoaesthesia
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
35.1%
13/37 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
8.1%
3/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
3/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.4%
2/37 • Number of events 2
|
|
Vascular disorders
Orthostatic hypotension
|
8.1%
3/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.1%
3/37 • Number of events 3
|
Additional Information
Department director of clinical development department 1
Nobelpharama
Phone: +81-3-5651-1177
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER