Trial · NCT07465718
Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
NCT07465718, Phase 3, Recruiting, Orphalan
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients. Trials, record NCT07465718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07465718
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
- NCT number
- NCT07465718
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 38 participants, estimated
- Lead sponsor
- Orphalan
- Conditions
- Wilson's Disease
- Interventions
- TETA 4HCl formulation, D-Penicillamine
- First posted
- 2026-03-12
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute value of serum NCC at Week 48 assessed using the NCC-speciation assay (serum NCC-Sp) | Week 48 | |
| Secondary | Serum NCC-Sp | Week 48 | Change from Baseline, within specified thresholds \[\>200, ≤ 200, ≤ 150, ≤ 100, ≤ 80, ≤ 50 μg/L and 50 to 80 μg/L\] |
| Secondary | 24-hour UCE | Week 48 | Absolute value, change from Baseline, within specified thresholds \[\< 100, \<200, \> 500, 150 to 500, and 200 to 500 μg/24h\] |
| Secondary | Investigator's assessment of signs and symptoms | Week 48 | Assessment of of the signs and symptoms of WD using GAS for WD, comprising a 4-item Global Disability (Tier 1) and 10-item Neurological Assessment (Tier 2). Total score, Tier 1 score, Tier 2 score, each item score. |
| Secondary | Clinical Global Impression of Change | Week 48 | Investigator rating of change in the patients WD relating to the prior clinic visit on a 7-point scale by responding to the following statement "Please rate the change in the overall severity of the patients Wilson's disease compared to the previous clinic visit". |
| Secondary | Clinical stability | Week 48 | As assessed by Independent Adjudication Committee, including final determination of the endpoint of clinical stability (yes/no), including successful de-coppering (as applicable). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07465718
GET https://conductscience.org/api/trials/v1/NCT07465718/registered