Comparison · NCT06128954-sae
Once Daily Dose Formulation (Treatment A) vs Cuprior® Comparator (Treatment B): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Once Daily Dose Formulation (Treatment A) vs Cuprior® Comparator (Treatment B): serious adverse events. Trial comparisons, record NCT06128954-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06128954-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.129 | wilson | |
| Risk in group 2 | 0 | 0 | 0.129 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.129 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Once Daily Dose Formulation (Treatment A) | 1 x 900mg TETA 4HCl, new once daily formulation (3x300mg trientine base tablets as a single AM dose)~900mg TETA 4HCl Once Daily Formulation: 3x300mg trientine base tablets as a single AM dose | 0 | 26 | EG000 |
| Group 2 | Cuprior® Comparator (Treatment B) | 2 x 450mg TETA 4HCl, Marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart)~900mg TETA 4HCl Cuprior®: 6 x150mg trientine base tablets in two equally divided doses | 0 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
- NCT number
- NCT06128954
- Phases
- PHASE1
- Conditions
- Wilson's Disease
- Interventions
- 900mg TETA 4HCl Once Daily Formulation, 900mg TETA 4HCl Cuprior®
- Lead sponsor
- Orphalan
- Results first posted
- 2025-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06128954?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT06128954-sae