ClinicalTrials.gg
Sign In
CompletedNCT01874028Updated Sep 19, 2014

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

A Phase 1 interventional study of trientine dihydrochloride in Wilson's Disease, sponsored by Univar BV. Completed at 1 site in Germany. Open to participants aged 6 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by Univar BV · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
6 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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 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.

02

Conditions studied

  • Wilson's Disease

Keywords

  • Trientine
  • Pharmacokinetics
03

In context

Hepatolenticular Degeneration

79 studies on the registry are indexed under Hepatolenticular Degeneration; 30 are open to participants now.

This study's enrollment of 20 is below the median of 29 across 43 interventional studies indexed under Hepatolenticular Degeneration.

Browse Hepatolenticular Degeneration studies →

Lead sponsor

Univar BV is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Trientine dihydrochloride

    Drug: trientine dihydrochloride

Interventions

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic measurements

    The main objective of the study is to evaluate the pharmacokinetics of a single dose of trientine dihydrochloride in children ≥6 years and adult patients with Wilson's disease by PK analysis. Non-compartmental or model-independent methods will be used to derive pharmacokinetic parameters using individual patient plasma concentration-time data. Pharmacokinetic parameters will include the Cmax, Tmax, T1/2, and the concentration-time curved (AUC0-t) and AUCinf.

    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

07

Study locations

1 site
  • Universitätsklinik Heidelberg
    Heidelberg, 69120, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Mar 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2013
First posted
Jun 10, 2013
Start
May 2013
Primary completionActual
Mar 2014
CompletionActual
Mar 2014
Last update
Sep 19, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01874028
Lead sponsor
Univar BV
Collaborators
Aptiv Solutions
Responsible party
Sponsor
First posted
Jun 10, 2013
Start date
May 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Sep 19, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Trientine

Other studies in this condition

Hepatolenticular Degeneration →

Other studies from this sponsor

Univar BV

Start the discussion