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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT01874028
Date of registration: 06/06/2013
Prospective Registration: Yes
Primary sponsor: Univar BV
Public title: A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients
Scientific title: A Phase 1 Pharmacokinetic Profiling Study in Patients Receiving Trientine Dihydrochloride for the Treatment of Wilson's Disease.
Date of first enrolment: May 2013
Target sample size: 20
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Children = 6 years and adult patients

2. Confirmed diagnosis of Wilson's disease by Leipzig-Score >3 (Ferenci et al 2003)

3. Current treatment with trientine dihydrochloride

4. Signed informed consent including parental consent in patients = 18 years

5. Agree to remain in the study site1 for the PK measurements period.

Exclusion Criteria:

1. Known clinically significant allergy or hypersensitivity to drugs that, in the
opinion of the investigator, may affect the patient's safety

2. Have any clinically significant conditions that would interfere with the collection
or interpretation of the study results or would compromise the patient's health

3. Women of child bearing potential who do not use contraceptives, breastfeeding, or
pregnant women

4. Severe anaemia (haemoglobin <9 mg/dL)

5. In the judgment of the Investigator, is likely to be noncompliant or uncooperative
during the study, or unable to cooperate because of a language problem or poor mental

6. Participation in any interventional clinical study at the same time or within the 4
weeks prior his study.

Age minimum: 6 Years
Age maximum: 90 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Wilson's Disease
Drug: trientine dihydrochloride
Primary Outcome(s)
Pharmacokinetic measurements [Time Frame: Evaluation of PK parameters will occur at 11 time points:Pre-dose), and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 hours post-dose]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Aptiv Solutions
Ethics review
Results available:
Date Posted:
Date Completed:
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