In short
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.
Key points
- Clinical trials of Trientine Dihydrochloride in the provided data focus on Wilson’s disease. The main study is a Phase 3 interventional trial with 51 participants. Researchers looked at how the treatment level in the blood relates to copper markers, including urinary copper, serum copper, ceruloplasmin, and non-ceruloplasmin bound copper. The study also examined patient characteristics that may affect treatment behavior in the body. The trial was completed.
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. It studied Trientine Dihydrochloride under the brand name Cufence in people with Wilson’s disease.
This trial was designed to characterize the relationship between dose, drug exposure, and copper markers in Wilson’s disease patients. 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.
Who was studied
The trial enrolled patients with Wilson’s disease, a condition named in the study record. A total of 51 participants were included.
The trial data do not list detailed inclusion or exclusion rules, so the source only confirms the target population at a general level.
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. The study measured the concentration of trientine in plasma, along with clearance and volume of distribution.
The trial also measured several copper markers to understand treatment response. These included 24-hour urinary copper excretion, non-ceruloplasmin bound copper, serum copper, and ceruloplasmin.
In simple terms, these markers help researchers see whether the study treatment is linked with changes in copper handling in the body.
Study design and phase
This was an interventional trial, meaning participants received the study treatment and researchers measured the effects. The study was in Phase 3, which is a later stage of clinical research.
The trial status was completed, so the study has already finished collecting its planned data.
Results-focused endpoints
The key endpoints were designed to connect treatment exposure with copper-related measures. This included plasma trientine levels, clearance, volume of distribution, and the listed copper markers.
- Plasma concentration: shows how much trientine is present in the blood at a given time.
- Clearance: shows how quickly the body removes the treatment.
- Volume of distribution: helps describe how widely the treatment spreads in the body.
- 24-hour urinary copper excretion: shows how much copper leaves the body in urine over one day.
- Serum copper, ceruloplasmin, and non-ceruloplasmin bound copper: blood-based measures used to track copper status in the study.
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. It also helps show whether patient features may change how the treatment behaves in the body.
Because the study was focused on modeling and measurement, it was not mainly about comparing many treatment groups. Instead, it aimed to build a clearer picture of treatment exposure and copper-related response in the studied patients.