Trial · NCT04573309
Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
NCT04573309, Phase 2, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2023-10-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840. Trials, record NCT04573309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04573309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
- NCT number
- NCT04573309
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Wilson Disease
- Interventions
- ALXN1840
- First posted
- 2020-10-05
- Last updated
- 2024-06-24
- Other registries' IDs
- eudract:2020-001104-41
- Results first posted
- 2023-10-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Daily Copper Balance: Day 1 Through Day 8 | Accumulation: Day 1 through Day 8 (ALXN1840 15 mg) | Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period. |
| Primary | Mean Daily Copper Balance: Day 31 Through Day 35 | Accumulation: Day 31 through Day 35 (ALXN1840 30 mg) | Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period. |
| Primary | Mean Daily Copper Balance: Day 25 Through Day 28 | Accumulation: Day 25 through Day 28 (ALXN1840 15 mg) | Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period. |
| Primary | Mean Daily Copper Balance: Day 36 Through Day 39 | Accumulation: Day 36 through Day 39 (ALXN1840 30 mg) | Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period. |
| Secondary | Change From Baseline In Mean Daily Copper Balance | Accumulation: Baseline, Day 1 through Day 8 (ALXN1840 15 mg) and Day 31 through Day 35 (ALXN1840 30 mg); Steady State: Baseline, Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period. |
| Secondary | Copper Quantified In Food, Drink, Feces, And Urine, Including Plasma Total And Labile Bound Copper (LBC) | Accumulation: Day 1 through Day 8 for 15 mg and Day 31 through Day 35 for 30 mg; Steady state: Day 25 through Day 28 for ALXN1840 15 mg and Day 36 through Day 39 for ALXN1840 30 mg | Copper was assessed through measurement of copper intake (in food and drink), and copper output (in feces and urine) as well as plasma total and labile bound copper. |
| Secondary | Molybdenum Specified In ALXN1840 Doses Given And Quantified In Food, Drink, Feces, And Urine, Including Plasma At Steady State | Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | The amount of molybdenum in food, drink, feces and urine is reported in this outcome measure. |
| Secondary | Change From Baseline In Total Molybdenum Excretion In Urine And Feces | Accumulation: Baseline, Day 1 through Day 8 (ALXN1840 15 mg) and Day 31 through Day 35 (ALXN1840 30 mg); Steady State: Baseline, Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | |
| Secondary | Mean Daily Molybdenum Balance At ALXN1840 Steady State | Steady state: Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | Molybdenum balance at steady state was assessed through measurement of molybdenum intake (in food, drink, and ALXN1840), and molybdenum output (in feces and urine). Steady state is defined as molybdenum (out) equal to molybdenum (in). |
| Secondary | Accumulation Of Molybdenum As Determined By Molybdenum Balance | Accumulation: Day 1 through Day 8 (ALXN1840 15 mg) and Day 31 through Day 35 ((ALXN1840 30 mg) | Molybdenum balance was assessed through measurement of molybdenum intake (in food, drink, and ALXN1840), and molybdenum output (in feces and urine). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Daily Copper Balance: Day 1 Through Day 8 | Accumulation: Day 1 through Day 8 (ALXN1840 15 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | milligrams/day | MEAN |
| SECONDARY | Change From Baseline In Mean Daily Copper Balance | Accumulation: Baseline, Day 1 through Day 8 (ALXN1840 15 mg) and Day 31 through Day 35 (ALXN1840 30 mg); Steady State: Baseline, Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | milligrams/day | MEAN |
| SECONDARY | Copper Quantified In Food, Drink, Feces, And Urine, Including Plasma Total And Labile Bound Copper (LBC) | Accumulation: Day 1 through Day 8 for 15 mg and Day 31 through Day 35 for 30 mg; Steady state: Day 25 through Day 28 for ALXN1840 15 mg and Day 36 through Day 39 for ALXN1840 30 mg | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | milligrams | MEAN |
| SECONDARY | Molybdenum Specified In ALXN1840 Doses Given And Quantified In Food, Drink, Feces, And Urine, Including Plasma At Steady State | Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | milligrams | MEAN |
| SECONDARY | Change From Baseline In Total Molybdenum Excretion In Urine And Feces | Accumulation: Baseline, Day 1 through Day 8 (ALXN1840 15 mg) and Day 31 through Day 35 (ALXN1840 30 mg); Steady State: Baseline, Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | milligrams | MEAN |
| SECONDARY | Mean Daily Molybdenum Balance At ALXN1840 Steady State | Steady state: Day 25 through Day 28 (ALXN1840 15 mg) and Day 36 through Day 39 (ALXN1840 30 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | milligrams/day | MEAN |
| SECONDARY | Accumulation Of Molybdenum As Determined By Molybdenum Balance | Accumulation: Day 1 through Day 8 (ALXN1840 15 mg) and Day 31 through Day 35 ((ALXN1840 30 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | milligrams | MEAN |
| PRIMARY | Mean Daily Copper Balance: Day 31 Through Day 35 | Accumulation: Day 31 through Day 35 (ALXN1840 30 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. | milligrams/day | MEAN |
| PRIMARY | Mean Daily Copper Balance: Day 25 Through Day 28 | Accumulation: Day 25 through Day 28 (ALXN1840 15 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. | milligrams/day | MEAN |
| PRIMARY | Mean Daily Copper Balance: Day 36 Through Day 39 | Accumulation: Day 36 through Day 39 (ALXN1840 30 mg) | Full analysis set included all participants who received at least 1 dose of ALXN1840 treatment. | milligrams/day | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Daily Copper Balance: Day 1 Through Day 8 | Cohort 1 | 0.8025 | Standard Deviation 0.26860 | milligrams/day | |
| Mean Daily Copper Balance: Day 1 Through Day 8 | Cohort 2 | 0.3062 | Standard Deviation NA | milligrams/day | |
| Change From Baseline In Mean Daily Copper Balance | Cohort 1 | Day 1 through Day 8 | -0.3780 | Standard Deviation 0.14822 | milligrams/day |
| Change From Baseline In Mean Daily Copper Balance | Cohort 2 | Day 1 through Day 8 | -0.2060 | Standard Deviation NA | milligrams/day |
| Change From Baseline In Mean Daily Copper Balance | Cohort 1 | Day 25 through Day 28 | -0.4697 | Standard Deviation 0.55770 | milligrams/day |
| Change From Baseline In Mean Daily Copper Balance | Cohort 2 | Day 25 through Day 28 | 0.1950 | Standard Deviation NA | milligrams/day |
| Change From Baseline In Mean Daily Copper Balance | Cohort 1 | Day 31 through Day 35 | -0.2650 | Standard Deviation 0.47135 | milligrams/day |
| Change From Baseline In Mean Daily Copper Balance | Cohort 2 | Day 31 through Day 35 | 0.1492 | Standard Deviation NA | milligrams/day |
| Change From Baseline In Mean Daily Copper Balance | Cohort 1 | Day 36 through Day 39 | -0.1831 | Standard Deviation 0.44589 | milligrams/day |
| Change From Baseline In Mean Daily Copper Balance | Cohort 2 | Day 36 through Day 39 | 0.0540 | Standard Deviation NA | milligrams/day |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 8 | |
| Overall Study | STARTED | Cohort 2 | 1 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cohort 1 | 8 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cohort 2 | 1 | |
| Overall Study | COMPLETED | Cohort 1 | 7 | |
| Overall Study | COMPLETED | Cohort 2 | 1 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 |
Source ClinicalTrials.gov
Adverse events38
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 | Constipation | Gastrointestinal disorders | Cohort 1 | 2 | 8 | 2 |
| other | Constipation | Gastrointestinal disorders | Cohort 2 | 1 | 1 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 1 | 1 | 8 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 2 | 0 | 1 | 0 |
| other | Hordeolum | Infections and infestations | Cohort 1 | 1 | 8 | 1 |
| other | Hordeolum | Infections and infestations | Cohort 2 | 0 | 1 | 0 |
| other | Periodontitis | Infections and infestations | Cohort 1 | 1 | 8 | 1 |
| other | Periodontitis | Infections and infestations | Cohort 2 | 0 | 1 | 0 |
| other | Pulpitis dental | Infections and infestations | Cohort 1 | 1 | 8 | 1 |
| other | Pulpitis dental | Infections and infestations | Cohort 2 | 0 | 1 | 0 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 8 |
| Total, all-cause mortality | Cohort 2 | 0 | 1 |
| Total, other adverse events | Cohort 1 | 6 | 8 |
| Total, other adverse events | Cohort 2 | 1 | 1 |
| Total, serious adverse events | Cohort 1 | 0 | 8 |
| Total, serious adverse events | Cohort 2 | 0 | 1 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: serious adverse events | Trial comparisons |
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/NCT04573309
GET https://conductscience.org/api/trials/v1/NCT04573309/results?page=2