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

NCT01874028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-09-19

No results posted yet for this study

Summary

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

Conditions

  • Wilson's Disease

Interventions

DRUG

trientine dihydrochloride

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

Sponsors & Collaborators

  • Aptiv Solutions

    collaborator INDUSTRY

  • Univar BV

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874028 on ClinicalTrials.gov