Trial · NCT03403205
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Daily Mean Area Under The Effect-time Curve (AUEC) of Directly Measured Non-ceruloplasmin-bound Copper (dNCC) From 0 to 48 Weeks (dNCC AUEC0-48W) | Baseline to Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. | micromoles (µmol)*hours (hr)/liter (L) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline up to Week 48 | Safety analysis set included all participants who received at least 1 dose of randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Unified Wilson Disease Rating Scale (UWDRS) Part II Total Score at Week 48 | Baseline, Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in UWDRS Part III Total Score at Week 48 | Baseline, Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in UWDRS Part III Functional Subscale Score at Week 48 | Baseline, Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in UWDRS Part III Individual Items/Subscales (Speech, Handwriting, Arising From a Chair, and Gait) Score at Week 48 | Baseline, Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression-Improvement Scale (CGI-I) Score at Week 48 | Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Week 48 | Baseline, Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Model for End-Stage Liver Disease (MELD) Score at Week 48 | Baseline, Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in Calculated Non-Ceruloplasmin Bound Copper (cNCC) or Calculated Non-Ceruloplasmin Bound Copper Corrected (cNCCcorrected) in Plasma at Week 48 | Baseline, Week 48 | Full analysis set: all randomized participants who received at least 1 dose of study drug. 'Overall number of participants analyzed'= participants evaluable for this outcome measure. | µmol/L | MEAN |
| SECONDARY | Percent Change From Baseline in cNCC or cNCCcorrected in Plasma at Week 48 | Baseline, Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | cNCC/cNCCcorrected Responder at Week 48 | Week 48 | Full analysis set included all randomized participants who received at least 1 dose of randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03403205/outcomes