Status:
COMPLETED
A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients
Lead Sponsor:
Univar BV
Collaborating Sponsors:
Aptiv Solutions
Conditions:
Wilson's Disease
Eligibility:
All Genders
6-90 years
Phase:
PHASE1
Brief Summary
To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients with Wilson's disease.
Detailed Description
An open, single-dose study to determine the pharmacokinetics, and safety of oral administration of trientine dihydrochloride in both children and adult patients with Wilson's Disease. Blood samples wi...
Eligibility Criteria
Inclusion
- Children ≥ 6 years and adult patients
- Confirmed diagnosis of Wilson's disease by Leipzig-Score \>3 (Ferenci et al 2003)
- Current treatment with trientine dihydrochloride
- Signed informed consent including parental consent in patients ≤ 18 years
- Agree to remain in the study site1 for the PK measurements period.
Exclusion
- Known clinically significant allergy or hypersensitivity to drugs that, in the opinion of the investigator, may affect the patient's safety
- Have any clinically significant conditions that would interfere with the collection or interpretation of the study results or would compromise the patient's health
- Women of child bearing potential who do not use contraceptives, breastfeeding, or pregnant women
- Severe anaemia (haemoglobin \<9 mg/dL)
- 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 development
- Participation in any interventional clinical study at the same time or within the 4 weeks prior his study.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01874028
Start Date
May 1 2013
End Date
March 1 2014
Last Update
September 19 2014
Active Locations (1)
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1
Universitätsklinik Heidelberg
Heidelberg, Germany, 69120