Trial · NCT02763215
The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
NCT02763215, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2020-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment. Trials, record NCT02763215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02763215
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
- NCT number
- NCT02763215
- Status
- Completed
- Enrollment
- 64 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Wilson Disease
- Interventions
- Standard of Care Medications
- First posted
- 2016-05-05
- Last updated
- 2020-12-01
- Results first posted
- 2020-10-26
- Limitations and caveats
- Only AEs associated with study-related interventional testing or assessments (that is, venipuncture) were collected.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Of Participants Who Achieved Or Maintained Normalized Concentrations Of Non-ceruloplasmin-bound Copper (NCC) Or Reached A Reduction Of ≥ 25% In NCC During 6 Months Of Treatment | Baseline through Month 6 | To achieve a normalized NCC concentration, participants must have had 2 consecutive measures within (or below) the normal concentration range (0.8 to 2.3 micromolar \[μM\]). Two consecutive measurements required that the measurements occurred on separate dates and were assigned to 2 different visits. Non-ceruloplasmin-bound copper was calculated by subtracting the amount of copper bound to the ceruloplasmin from the total plasma copper concentration. |
| Secondary | Percentage Of Participants Who Achieved Or Maintained Normalized Concentrations Of NCC Or Reached A Reduction Of ≥ 25% In NCC Through Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | To achieve a normalized NCC concentration, participants must have 2 consecutive measures within (or below) the normal range (0.8 to 2.3 μM). Two consecutive measurements required that the measurements occurred on separate dates and were assigned to 2 different visits. Non-ceruloplasmin-bound copper was calculated by subtracting the amount of copper bound to the ceruloplasmin from the total plasma copper concentration. Last Assessment was the last available post-baseline result for each participant (ranging from 1 to 24 months). |
| Secondary | Change From Baseline In NCC Concentrations At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Evaluation of NCC concentrations over time are reported as micromoles/liter (μmol/L). Last Assessment was the last available post-baseline result for each participant (ranging from 1 to 24 months). |
| Secondary | Time To Normalization Of NCC If Above The Reference Range At The Time Of Enrollment | Baseline, up to 24 months | The time to normalization of NCC was measured by Kaplan-Meier analysis. |
| Secondary | Change From Baseline In Exchangeable Copper At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | The change in exchangeable copper was evaluated over time and is reported as nanograms/milliliter (ng/mL). Last Assessment was the last available post-baseline result for each participant (ranging from 1 to 24 months). |
| Secondary | Change From Baseline In Copper Plasma Ultrafiltrate At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Change in copper plasma ultrafiltrate was measured over time and is reported as ng/mL. Last Assessment was the last available post-baseline result for each participant (ranging from 1 to 24 months). |
| Secondary | Change From Baseline In Plasma Total Copper Used To Calculate NCC At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Plasma total copper was measured over time and is reported as ng/mL. Last Assessment was the last available post-baseline result for each participant (ranging from 1 to 24 months). |
| Secondary | Change From Baseline In Serum Total Ceruloplasmin (Nephelometry) Used To Calculate NCC At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | The total serum (nephelometry) was measured over time and is reported as milligrams (mg)/L. Last Assessment was the last available post-baseline result for each participant (ranging from 1 to 24 months). |
| Secondary | Change From Baseline In 24-Hour Urinary Copper At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Evaluation of 24-hour urinary copper over time is reported as micrograms (μg)/day. Last Assessment was the last available post-baseline result for each participant (ranging from 1 to 24 months). |
| Secondary | Change From Baseline In Plasma Total Molybdenum At Month 6 And Month 24 | Baseline, Month 6, Month 24 | The plasma total molybdenum was measured over time and is reported in ng/mL. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Of Participants Who Achieved Or Maintained Normalized Concentrations Of Non-ceruloplasmin-bound Copper (NCC) Or Reached A Reduction Of ≥ 25% In NCC During 6 Months Of Treatment | Baseline through Month 6 | Full Analysis Set: Participants enrolled in the study. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Who Achieved Or Maintained Normalized Concentrations Of NCC Or Reached A Reduction Of ≥ 25% In NCC Through Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Full Analysis Set: Participants enrolled in the study. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline In NCC Concentrations At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Full Analysis Set: Enrolled participants. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. The number of participants analyzed per row represents number of overall participants continuing in the study at each timepoint with non-missing and non-negative baseline and post-baseline values for NCC. | μmol/L | MEAN |
| SECONDARY | Time To Normalization Of NCC If Above The Reference Range At The Time Of Enrollment | Baseline, up to 24 months | Full Analysis Set with an elevated NCC at Baseline. | Days | MEDIAN |
| SECONDARY | Change From Baseline In Exchangeable Copper At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Full Analysis Set: Enrolled participants. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. The number of participants analyzed per row represents number of overall participants continuing in the study at each timepoint with non-missing baseline and post-baseline values for each outcome measure. | ng/mL | MEAN |
| SECONDARY | Change From Baseline In Copper Plasma Ultrafiltrate At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Full Analysis Set: Enrolled participants. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. The number of participants analyzed per row represents number of overall participants continuing in the study at each timepoint with non-missing baseline and post-baseline values for each outcome measure. | ng/mL | MEAN |
| SECONDARY | Change From Baseline In Plasma Total Copper Used To Calculate NCC At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Full Analysis Set: Enrolled participants. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. The number of participants analyzed per row represents number of overall participants continuing in the study at each timepoint with non-missing baseline and post-baseline values for each outcome measure. | ng/mL | MEDIAN |
| SECONDARY | Change From Baseline In Serum Total Ceruloplasmin (Nephelometry) Used To Calculate NCC At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Full Analysis Set: Enrolled participants. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. The number of participants analyzed per row represents number of overall participants continuing in the study at each timepoint with non-missing baseline and post-baseline values for each outcome measure. | mg/L | MEDIAN |
| SECONDARY | Change From Baseline In 24-Hour Urinary Copper At Month 6, Month 24, And Last Assessment | Baseline through Last Assessment (ranging from 1 to 24 months) | Full Analysis Set: Enrolled participants. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. The number of participants analyzed per row represents number of overall participants continuing in the study at each timepoint with non-missing baseline and post-baseline values for each outcome measure. | μg/day | MEAN |
| SECONDARY | Change From Baseline In Plasma Total Molybdenum At Month 6 And Month 24 | Baseline, Month 6, Month 24 | Full Analysis Set: Enrolled participants. To be eligibly enrolled, participants must have been receiving the SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment. The number of participants analyzed per row represents number of overall participants continuing in the study at each timepoint with non-missing baseline and post-baseline values for each outcome measure. | ng/mL | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Of Participants Who Achieved Or Maintained Normalized Concentrations Of Non-ceruloplasmin-bound Copper (NCC) Or Reached A Reduction Of ≥ 25% In NCC During 6 Months Of Treatment | Total | 51.6 | 95% Confidence Interval 51.2 to 78.8 | Percentage of participants | |
| Percentage Of Participants Who Achieved Or Maintained Normalized Concentrations Of NCC Or Reached A Reduction Of ≥ 25% In NCC Through Last Assessment | Total | 62.5 | 95% Confidence Interval 59.0 to 83.9 | Percentage of participants | |
| Change From Baseline In NCC Concentrations At Month 6, Month 24, And Last Assessment | Total | Month 6 | -0.60 | Standard Deviation 1.441 | μmol/L |
| Change From Baseline In NCC Concentrations At Month 6, Month 24, And Last Assessment | Total | Month 24 | -1.24 | Standard Deviation 1.905 | μmol/L |
| Change From Baseline In NCC Concentrations At Month 6, Month 24, And Last Assessment | Total | Last Assessment | -0.94 | Standard Deviation 1.811 | μmol/L |
| Time To Normalization Of NCC If Above The Reference Range At The Time Of Enrollment | Total | 139.5 | Inter-Quartile Range 62.0 to 545.0 | Days | |
| Change From Baseline In Exchangeable Copper At Month 6, Month 24, And Last Assessment | Total | Month 6 | -7.9 | Standard Deviation 26.02 | ng/mL |
| Change From Baseline In Exchangeable Copper At Month 6, Month 24, And Last Assessment | Total | Month 24 | -9.5 | Standard Deviation 27.61 | ng/mL |
| Change From Baseline In Exchangeable Copper At Month 6, Month 24, And Last Assessment | Total | Last Assessment | -8.3 | Standard Deviation 27.25 | ng/mL |
| Change From Baseline In Copper Plasma Ultrafiltrate At Month 6, Month 24, And Last Assessment | Total | Month 6 | -3.96 | Standard Deviation 13.082 | ng/mL |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total | 64 | |
| Overall Study | COMPLETED | Total | 57 | |
| Overall Study | NOT COMPLETED | Total | 7 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Haematoma | Vascular disorders | Total | 1 | 64 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total | 1 | 64 |
| Total, other adverse events | Total | 1 | 64 |
| Total, serious adverse events | Total | 0 | 64 |
Source ClinicalTrials.gov
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/NCT02763215
GET https://conductscience.org/api/trials/v1/NCT02763215/results?page=2