Clinical Trials List
Protocol NumberSPC-MU-201903
Active
2025-02-01 - 2029-02-01
Phase IV
Recruiting2
ICD-10E83.00
Disorder of copper metabolism, unspecified
ICD-10E83.01
Wilson's disease
ICD-10E83.09
Other disorders of copper metabolism
ICD-9275.1
Disorders of copper metabolism
A prospective, observational trial to evaluate the safety and efficacy of copper sulfate® capsules in treating patients with Wilson's disease.
-
Trial Applicant
SHINER PHARM CORP.
-
Sponsor
shinerpharm corp.
-
Trial scale
Taiwan Single Center
-
Update
2026/08/27
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chin-Chang Huang
Co-Principal Investigator
- 吳逸如 Division of Neurology
- 張庭瑜 Division of Neurology
- Chi-Hung Liu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Wilson's disease
Objectives
The purpose of this trial was to collect and evaluate the efficacy and safety of Trientine Dihydrochloride capsules for patients with Wilson's disease.
Test Drug
MetaCu® Capsules 300mg
Active Ingredient
Trientine Dihydrochloride
Dosage Form
Capsules
Dosage
300
Endpoints
Serum non-ceruloplasmin bound copper concentration (NCC or free copper) at week 48 after medication.
Serium non-ceruloplasmin bound copper concentration (mcg/dL) = Total serum copper ion concentration (mcg/dL) – Concentration of ions bound to ceruloplasmin (mcg/dL)
Serium non-ceruloplasmin bound copper concentration (mcg/dL) = Total serum copper ion concentration (mcg/dL) – Concentration of ions bound to ceruloplasmin (mcg/dL)
Inclution Criteria
Key Inclusion Criteria:
Both male and female, aged 20 to 75 years; confirmed diagnosis of Wilson's disease; treatment-naïve participants.
Key Exclusion Criteria:
Uncompensated cirrhosis; End-stage liver disease scoring system score >11 points; Gastrointestinal bleeding within the past three months; Hemoglobin level <9 g/dL; Renal insufficiency.
Both male and female, aged 20 to 75 years; confirmed diagnosis of Wilson's disease; treatment-naïve participants.
Key Exclusion Criteria:
Uncompensated cirrhosis; End-stage liver disease scoring system score >11 points; Gastrointestinal bleeding within the past three months; Hemoglobin level <9 g/dL; Renal insufficiency.
Exclusion Criteria
Subjects will be excluded if they meet any of the following criteria:
(1) Possessing uncompensated cirrhosis.
(2) Suffering from a neurological disorder requiring nasogastric tube feeding or intensive care.
(3) Subjects with active malignant tumors, but whose tumors have been cured as determined by the trial administrator/physician, or who have received treatment and have not relapsed within the past five years, may be included in this trial.
(4) Subjects testing positive for hepatitis B virus (HBV, positive for hepatitis B surface antigen [HBsAg]), hepatitis C virus (HCV, positive for anti-hepatitis C virus antibody), or human immunodeficiency virus (HIV). However, subjects with the above positive test results may be included in this trial if the trial administrator/physician determines that the infection is inactive.
(5) Subjects with any clinically significant illness, medical condition, surgical history, physiological problems, or abnormal laboratory test values, which the trial administrator/physician determines may affect the subject's safety. (6) And any of the following treatments: gold therapy, antimalarial treatment, cytotoxic anticancer drugs (antineoplastics), oxyphenbutazone, and phenylbutazone.
(7) Unwilling or unable to comply with the routine visits, dosing regimens, laboratory tests, or other trial-related procedures and restrictions of this trial.
(1) Possessing uncompensated cirrhosis.
(2) Suffering from a neurological disorder requiring nasogastric tube feeding or intensive care.
(3) Subjects with active malignant tumors, but whose tumors have been cured as determined by the trial administrator/physician, or who have received treatment and have not relapsed within the past five years, may be included in this trial.
(4) Subjects testing positive for hepatitis B virus (HBV, positive for hepatitis B surface antigen [HBsAg]), hepatitis C virus (HCV, positive for anti-hepatitis C virus antibody), or human immunodeficiency virus (HIV). However, subjects with the above positive test results may be included in this trial if the trial administrator/physician determines that the infection is inactive.
(5) Subjects with any clinically significant illness, medical condition, surgical history, physiological problems, or abnormal laboratory test values, which the trial administrator/physician determines may affect the subject's safety. (6) And any of the following treatments: gold therapy, antimalarial treatment, cytotoxic anticancer drugs (antineoplastics), oxyphenbutazone, and phenylbutazone.
(7) Unwilling or unable to comply with the routine visits, dosing regimens, laboratory tests, or other trial-related procedures and restrictions of this trial.
The Estimated Number of Participants
-
Taiwan
24 participants
-
Global
24 participants
