A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

Brief Summary

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To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients with Wilson's disease.

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Detailed Description

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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 will be taken pre-dose and at 10 time-points post-dose to investigate the pharmacokinetic profile of trientine dihydrochloride up to 12 hours after intake of study medication in 20 patients.

Conditions

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Wilson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trientine dihydrochloride

Group Type EXPERIMENTAL

trientine dihydrochloride

Intervention Type DRUG

Patients will take their normal prescribed dose (x1) of trientine dihydrochloride 300mg

Interventions

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trientine dihydrochloride

Patients will take their normal prescribed dose (x1) of trientine dihydrochloride 300mg

Intervention Type DRUG

Eligibility Criteria

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No