Trial · NCT07010575
Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
NCT07010575, Phase 2, Completed, Orphalan
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride. Trials, record NCT07010575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07010575
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
- NCT number
- NCT07010575
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Orphalan
- Conditions
- Wilson's Disease
- Interventions
- New TETA 4HCl Formulation, Standard of Care
- First posted
- 2025-06-08
- Last updated
- 2026-04-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess and compare patient preference, convenience and satisfaction between current standard of care treatments for Wilson's Disease and the new TETA 4HCl formulation using patient reported outcome questionnaires. | From the screening assessment (-28 days to Day 1) to end of study at Week 8 | Mean Treatment Satisfaction Questionnaire for Medication (TSQM-9) score over time including change from baseline by domain |
| Primary | Assess and compare patient preference, convenience and satisfaction between current standard of care treatments for Wilson's Disease and the new TETA 4HCl formulation using patient reported outcome questionnaires. | From the screening assessment (-28 days to Day 1) to end of study at Week 8 | Incidence of categorical posology questions over time |
| Secondary | Assess treatment adherence and tolerability of a new TETA 4HCl formulation. | From the screening assessment (-28 days to Day 1) to end of study at Week 8 | Mean Morisky Medication Adherence Scale-8 (MMAS-8) score over time including change from baseline |
| Secondary | Assess treatment adherence and tolerability of a new TETA 4HCl formulation. | From the screening assessment (-28 days to Day 1) to end of study at Week 8 | Incidence of categorical laboratory safety data and adverse events (AE) assessments during the study. |
| Secondary | Assess treatment adherence and tolerability of a new TETA 4HCl formulation. | From the screening assessment (-28 days to Day 1) to end of study at Week 8 | Mean of continuous laboratory safety data during the study |
| Other | Assess markers of copper balance with a new TETA 4HCl formulation. | From the screening assessment (-28 days to Day 1) to end of study at Week 8 | Mean Serum NCC values as assessed by speciation assay (NCC-Sp); |
| Other | Qualitative data analysis following a semi-structured patient interview designed to develop a WD-specific PRO measure. | From Day 14 to Day 28 | Cognitive validation of a novel Wilson's disease-specific patient reported outcome measure under development using qualitative patient interview data on disease and therapy. |
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/NCT07010575
GET https://conductscience.org/api/trials/v1/NCT07010575/registered