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Trientine Dihydrochloride

Clinical trials are studying Trientine Dihydrochloride in people with Wilson’s disease. These studies look at how the treatment behaves in the body and how it relates to copper markers, with a focus on safety-related research goals and treatment response in adult patients.

Table of Contents

Trial overview

The main study in the data is a prospective study, which means researchers planned the study ahead of time and followed participants forward during the trial.[1] It studied Trientine Dihydrochloride under the brand name Cufence in people with Wilson’s disease.[1]

This trial was designed to characterize the relationship between dose, drug exposure, and copper markers in Wilson’s disease patients.[1] The study also aimed to evaluate how patient characteristics may influence important model values, such as apparent clearance, apparent volume of distribution, and drug potency.[1]

Who was studied

The trial enrolled patients with Wilson’s disease, a condition named in the study record.[1] A total of 51 participants were included.[1]

The trial data do not list detailed inclusion or exclusion rules, so the source only confirms the target population at a general level.[1]

What was measured

The primary outcomes focused on pharmacokinetics, which describes how much of the treatment is in the body and how the body handles it over time.[1] The study measured the concentration of trientine in plasma, along with clearance and volume of distribution.[1]

The trial also measured several copper markers to understand treatment response.[1] These included 24-hour urinary copper excretion, non-ceruloplasmin bound copper, serum copper, and ceruloplasmin.[1]

In simple terms, these markers help researchers see whether the study treatment is linked with changes in copper handling in the body.[1]

Study design and phase

This was an interventional trial, meaning participants received the study treatment and researchers measured the effects.[1] The study was in Phase 3, which is a later stage of clinical research.[1]

The trial status was completed, so the study has already finished collecting its planned data.[1]

Results-focused endpoints

The key endpoints were designed to connect treatment exposure with copper-related measures.[1] This included plasma trientine levels, clearance, volume of distribution, and the listed copper markers.[1]

  • Plasma concentration: shows how much trientine is present in the blood at a given time.[1]
  • Clearance: shows how quickly the body removes the treatment.[1]
  • Volume of distribution: helps describe how widely the treatment spreads in the body.[1]
  • 24-hour urinary copper excretion: shows how much copper leaves the body in urine over one day.[1]
  • Serum copper, ceruloplasmin, and non-ceruloplasmin bound copper: blood-based measures used to track copper status in the study.[1]

What these results mean for patients

For patients, this type of trial helps researchers understand whether Trientine Dihydrochloride is linked with expected changes in copper markers in Wilson’s disease.[1] It also helps show whether patient features may change how the treatment behaves in the body.[1]

Because the study was focused on modeling and measurement, it was not mainly about comparing many treatment groups.[1] Instead, it aimed to build a clearer picture of treatment exposure and copper-related response in the studied patients.[1]

Trial ID Phase Condition studied Status Enrollment
2024-516431-27-00 Phase 3 Wilson’s Disease Completed 51

FAQ

  • What is being studied in Trientine Dihydrochloride trials? The trial is studying how Trientine Dihydrochloride exposure relates to copper markers in people with Wilson’s disease. It also looks at patient features that may affect how the treatment acts in the body.
  • Who can take part in these trials? The study enrolled patients with Wilson’s disease. The trial data do not give more detailed entry rules, such as age limits or other health requirements.
  • What phase is the Trientine Dihydrochloride trial? The study is a Phase 3 trial. This means it is a later-stage clinical study that helps researchers learn more about the treatment in a patient group.
  • What outcomes are measured? The trial measures trientine concentration in plasma, clearance, volume of distribution, and several copper markers. These include 24-hour urinary copper excretion, serum copper, ceruloplasmin, and non-ceruloplasmin bound copper.
  • What was the status of the study? The trial was completed. It enrolled 51 participants.

Ongoing Clinical Trials on Trientine Dihydrochloride

  • Study of Trientine Dihydrochloride (Cufence) to Evaluate Its Effects and Safety in Patients with Wilson’s Disease

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Denmark France Germany Poland

Glossary

  • Wilson’s disease: A condition studied in this trial. It is the disease the researchers were focusing on when testing Trientine Dihydrochloride.
  • Phase 3: A later stage of clinical research. These studies usually include more patients and help researchers learn more about how a treatment performs.
  • Interventional study: A study where participants receive a treatment or intervention so researchers can measure its effects.
  • Pharmacokinetics: How the body handles a treatment over time, including how much of it is in the blood.
  • Pharmacodynamics: How a treatment affects the body. In this trial, the focus was on copper-related markers.
  • Plasma concentration: The amount of a substance found in the liquid part of the blood.
  • Clearance: How quickly the body removes a treatment.
  • Volume of distribution: A measure used to describe how a treatment spreads through the body.
  • 24-hour urinary copper excretion: The amount of copper passed out in urine over 24 hours. It is used here as a copper marker.
  • Ceruloplasmin: A blood protein that carries copper. It was measured as one of the copper markers in this study.
  • Non-ceruloplasmin bound copper (NCC): Copper in the blood that is not attached to ceruloplasmin. It was one of the study’s copper markers.

References

  1. https://clinicaltrials.gov/study/2024-516431-27-00