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Comparison · NCT06128954-deaths

Once Daily Dose Formulation (Treatment A) vs Cuprior® Comparator (Treatment B): deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Once Daily Dose Formulation (Treatment A) vs Cuprior® Comparator (Treatment B): deaths from any cause. Trial comparisons, record NCT06128954-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06128954-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.129wilson
Risk in group 2000.129wilson
Risk difference, group 1 minus group 20-0.1290.129newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Once 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 dose026EG000
Group 2Cuprior® 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
026EG001

Harm

What it counts
Total, all-cause mortality
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

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.

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