NCT04573309 — consolidated Schedule of Activities

usdm_data · 2 tables · 44 activities (4% compression) · 35 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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Common
▼ Main Schedule (24 columns)
ActivityInTable 1
Study Phase26
[epoch] L1		Screening1Screening1C-I23UNS4EOS or ET5
Period
[period] L2		ScreeningScreeningC-IInpatient Period 1Inpatient Period 1Inpatient Period 1Inpatient Period 1Inpatient Period 1Inpatient Period 1Inpatient Period 1Inpatient Period 1OPInpatient Period 2Inpatient Period 2Inpatient Period 2Inpatient Period 2Inpatient Period 2Inpatient Period 2Inpatient Period 2Inpatient Period 2Inpatient Period 2
Days
[study_day] L3		-42 to -9-21-8-7-6 through -5-4 through -112-34-78910-2223242526-282930-353637-383940EOS Day 54+/-2
EligibilityT1
Informed consentT1X
Admit to unitT1XX
Discharge from unit6T1XX
Outpatient visit or phone callT1X7
Inclusion/exclusionT1XXX
Discuss/document contraceptionT1XXXX
Follicle-stimulating hormone (post-menopausal females only)8T1X
Alcohol testT1XX
Urine drug screenT1XX
HIV, hepatitis B and C screenT1X
Study AdministrationT1
Medical history/demographics9T1X
WD history10T1X
Prior WD treatment10T1XX
Physical examination11T1XXXX
Height, weight, and BMI12T1XXXX
EnrollmentT1
Enrollment/inclusionT1X
Discontinue chelation therapyT1X→→→→→→→→→→→→→→→→→→
Discontinue zinc therapyT1X→→→→→→→→→→→→→→→→→→→→→→
Administration of Study Intervention13T1
ALXN1840 15 mg/dayT1XXXXXXXXXX
ALXN1840 30 mg/dayT1XXXXX
Study intervention complianceT1X14X
PK/PD Analyses15T1
Blood sampling for PK: Plasma total Mo and PUF-MoT1,T2X16XX16XX16XXXX16X
PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu25T1,T2
Safety Assessments / Laboratory AnalysesT1
Chemistry, hematology, Coagulation17T1XXX18XX7XX18XXX
UrinalysisT1XXXX7XXXX
Urine/serum pregnancy test19T1XXXX
Retained serum sample (safety)20T1X
Vitals sign measurements21T1XXXXXXX
12-lead ECG (triplicate)T1XXXXXXX
Adverse eventsT1XXXXXXXXXXXXXXXXXXXXXX
Balance assessmentsT1
Cu/Mo-controlled meals22T1XXXXXXXXXXXXXXXX
Light exercise regimenT1XXXXXXXXXXXXXXXXXX
Urination and bowel movement monitoring, menstruation check19T1XXXXXXXXXXXX
24-hour urine for Cu and Mo23T1XXXXXXXXXXXX
Feces for Cu and Mo24T1XXXXXXXXXXXX
OtherT1
Concomitant medication and non-pharmacologic therapy/procedureT1XXXXXXXXXXXXXXXXXXXXXX
▼ Subsidiary Schedule (11 columns)
ActivityInTable 2
Time point (hours)
[timepoint] L1		−0.5012345681224
EligibilityT1
Study AdministrationT1
EnrollmentT1
Administration of Study Intervention13T1
PK/PD Analyses15T1
Blood sampling for PK: Plasma total Mo and PUF-MoT1,T2XXXXXXXX27
PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu25T1,T2XXXXXXXX27
Safety Assessments / Laboratory AnalysesT1
Balance assessmentsT1
OtherT1
▼ Matches across tables no matches to review
Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT04573309_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.
Refinements: a table or row that details a row of another table, without being the same activity. A cross-reference note can draft the entry once the table it means is picked; row-to-row entries are written by hand.
staterefining siderowactivitydraft
source note 15 “Blood sampling for PK/PD will occur before ALXN1840 administration and represents a predose trough. See Table 2 for PK/PD sampling on Days 1, 25, 29, and 39.” points from T1 act-026 PK/PD Analyses
source note 16 “PK/PD collection will include timepoints described in the schedule of PK/PD assessment for Days 1, 25, 29, and 39 (Table 2).” points from T1 act-027 Blood sampling for PK: Plasma total Mo and PUF-Mo
Draft — new file consolidated/NCT04573309_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:36.910302+00:00
source_activity_count46
unified_activity_count44
compression_percent4
match_statsexact: 2, new: 44
▼ Source Tables 2 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Table 1: Schedule of Activities
Main study schedule from Screening through EOS/ET (Day 54+/-2), including both inpatient periods and the outpatient interval		 44 24 3
T2 subsidiary Table 2: Schedule of Pharmacokinetic and Pharmacodynamic Assessments on Days 1, 25, 29, and 39
Hour-level PK/PD sampling times on Days 1, 25, 29 and 39		 2 11 1
▼ Property Hierarchy Comparison 2 main timeline tables, 3 levels max

Compares main timeline tables only (main_soa, continuation, subsidiary). Track, domain, and reference tables excluded — different structure by design.

LevelT1T2Conclusion
L1
Study Phase
[epoch]
Top header band: 'Screening' (Days -42 to -9 and -21), 'C-I' (check-in, Day -8), a blank merged cell over Days -7 to 40, 'UNS' (unscheduled) and 'EOS or ET'. The label column for rows 1-2 is a single merged cell reading 'Study Procedures' (the activity-column heading), so the property name is synthesised. Typed epoch because the values name study phases/visit categories spanning columns; distinguishes the UNS column (whose Days cell is empty) from the others.
Time point (hours)
[timepoint]
Hours relative to dosing (0 hours) on Days 1, 25, 29 and 39: −0.5, 0, 1, 2, 3, 4, 5, 6, 8, 12, 24. Within-day sampling times -> timepoint.
≠ Differs
L2
Period
[period]
Second header band: 'Screening', 'C-I', 'Inpatient Period 1' (merged over Days -7 to 9), 'OP' (outpatient, Days 10-22), blank at Day 23, 'Inpatient Period 2' (merged over Days 24 to 40), blank under UNS and EOS/ET. Sub-phases of the treatment phase -> period. Label cell is part of the merged 'Study Procedures' cell, so name synthesised.
—1/2 tables
L3
Days
[study_day]
Study days / day ranges relative to first ALXN1840 dose (Day 1): -42 to -9 ... 40, blank under UNS, and 'EOS Day 54+/-2'. Printed label 'Days' -> study_day.
—1/2 tables
▼ Unified Activities 44 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Eligibility one table 1 T1 section
xact-002 Informed consent Eligibility one table 1 T1
xact-003 Admit to unit Eligibility one table 1 T1
xact-004 Discharge from unit Eligibility one table 1 T1
xact-005 Outpatient visit or phone call Eligibility one table 1 T1
xact-006 Inclusion/exclusion Eligibility one table 1 T1
xact-007 Discuss/document contraception Eligibility one table 1 T1
xact-008 Follicle-stimulating hormone (post-menopausal females only) Eligibility one table 1 T1
xact-009 Alcohol test Eligibility one table 1 T1
xact-010 Urine drug screen Eligibility one table 1 T1
xact-011 HIV, hepatitis B and C screen Eligibility one table 1 T1
xact-012 Study Administration one table 1 T1 section
xact-013 Medical history/demographics Study Administration one table 1 T1
xact-014 WD history Study Administration one table 1 T1
xact-015 Prior WD treatment Study Administration one table 1 T1
xact-016 Physical examination Study Administration one table 1 T1
xact-017 Height, weight, and BMI Study Administration one table 1 T1
xact-018 Enrollment one table 1 T1 section
xact-019 Enrollment/inclusion Enrollment one table 1 T1
xact-020 Discontinue chelation therapy Enrollment one table 1 T1
xact-021 Discontinue zinc therapy Enrollment one table 1 T1
xact-022 Administration of Study Intervention one table 1 T1 section
xact-023 ALXN1840 15 mg/day Administration of Study Intervention one table 1 T1
xact-024 ALXN1840 30 mg/day Administration of Study Intervention one table 1 T1
xact-025 Study intervention compliance Administration of Study Intervention one table 1 T1
xact-026 PK/PD Analyses one table 1 T1 section
xact-027 Blood sampling for PK: Plasma total Mo and PUF-Mo PK/PD Analyses same name 2 T1, T2
xact-028 PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu PK/PD Analyses same name 2 T1, T2
xact-029 Safety Assessments / Laboratory Analyses one table 1 T1 section
xact-030 Chemistry, hematology, Coagulation Safety Assessments / Laboratory Analyses one table 1 T1
xact-031 Urinalysis Safety Assessments / Laboratory Analyses one table 1 T1
xact-032 Urine/serum pregnancy test Safety Assessments / Laboratory Analyses one table 1 T1
xact-033 Retained serum sample (safety) Safety Assessments / Laboratory Analyses one table 1 T1
xact-034 Vitals sign measurements Safety Assessments / Laboratory Analyses one table 1 T1
xact-035 12-lead ECG (triplicate) Safety Assessments / Laboratory Analyses one table 1 T1
xact-036 Adverse events Safety Assessments / Laboratory Analyses one table 1 T1
xact-037 Balance assessments one table 1 T1 section
xact-038 Cu/Mo-controlled meals Balance assessments one table 1 T1
xact-039 Light exercise regimen Balance assessments one table 1 T1
xact-040 Urination and bowel movement monitoring, menstruation check Balance assessments one table 1 T1
xact-041 24-hour urine for Cu and Mo Balance assessments one table 1 T1
xact-042 Feces for Cu and Mo Balance assessments one table 1 T1
xact-043 Other one table 1 T1 section
xact-044 Concomitant medication and non-pharmacologic therapy/procedure Other one table 1 T1
▼ Unified Annotations 28 annotations (0% dedup from 28)
Footnote (28)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 Within 42 days of ALXN1840 administration. Details of procedures that may be performed by sites designated as “screening sites” (only in the US) are detailed in Section 8. -42 to -9 | -21 Section 8
xannot-002 2 T1:b 1 Participants will be admitted to the clinical research unit (CRU) at least 10 hours prior to enrollment and initiation of copper- and molybdenum-controlled diet. -8
xannot-003 3 T1:c 1 At the CRU’s discretion, participants may remain in the CRU or be readmitted on Day 22 with all procedures starting on Day 23. 10-22
xannot-004 4 T1:d 1 Unscheduled study visits may occur at any time during the study and may include any study procedure as deemed necessary by the Investigator. UNS
xannot-005 5 T1:e 1 Participants are required to return to the CRU Day 54+/-2; participants will be discontinued from ALXN1840 medication by their physician at the latest by the Day 54 follow-up. EOS Day 54+/-2
xannot-006 6 T1:f 1 Discharge from the unit may occur after completion of all procedures on Day 9 and on Day 40 and after the Investigator has reviewed all safety assessment (including safety laboratory tests) and confirmed that the participant is appropriate for discharge. Discharge from unit
xannot-007 7 T1:g 1 A single outpatient visit or phone call and safety laboratory assessment should occur between Day 14 and Day 18. A phone call may take place on a different day than the blood draw within the Day 14 through Day 18 period. Outpatient visit or phone call | Chemistry, hematology, Coagulation | Urinalysis 3 cells
xannot-008 8 T1:h 1 If needed to confirm menopause. Follicle-stimulating hormone (post-menopausal females only)
xannot-009 9 T1:i 1 Parameters include age and sex. Race and ethnicity will be collected where permitted by local regulations. Medical history/demographics
xannot-010 10 T1:j 1 Wilson disease history will include diagnosis date, method of diagnosis, history of cirrhosis, details of any previous liver biopsies performed, and treatment received. WD history | Prior WD treatment
xannot-011 11 T1:k 1 A full physical examination will be performed at Screening, at check-in for the study, and at the End of the study/Early Termination Visit. A physical examination should also be performed on any participants with ongoing adverse events prior to discharge from the unit. Otherwise, a symptom-driven physical examination may be performed at other times, at the Principal Investigator’s discretion. Physical examination
xannot-012 12 T1:l 1 Height at screening only. Height, weight, and BMI
xannot-013 13 T1:m 1 While in the CRU, study intervention will be administered after an overnight fast (ie, at least 10 hours) at the same time every morning; drug is to be administered with 240 mL of water and meals should be delayed a minimum of 2 hours after dosing. As an outpatient, participants are expected to take ALXN1840 at approximately the same time daily (+/-1 hour). Participants should take the medication with a glass of water on an empty stomach; meals should be delayed a minimum of 2 hours after dosing. Administration of Study Intervention
xannot-014 14 T1:n 1 During the outpatient period, participants will use SMS text messaging to confirm study intervention administration. Study intervention compliance 1 cells
xannot-015 15 T1:o 1 Blood sampling for PK/PD will occur before ALXN1840 administration and represents a predose trough. See Table 2 for PK/PD sampling on Days 1, 25, 29, and 39. PK/PD Analyses Table 2 (T2)
xannot-016 16 T1:p 1 PK/PD collection will include timepoints described in the schedule of PK/PD assessment for Days 1, 25, 29, and 39 (Table 2). Blood sampling for PK: Plasma total Mo and PUF-Mo 4 cells Table 2 (T2)
xannot-017 17 T1:q 1 Samples for serum chemistry will be obtained following a fast of at least 8 hours at the Screening Visit and at check-in. In case of rechecks, and postdose serum chemistry, participants may not have fasted for 6 or 8 hours before the serum chemistry sample is taken. Chemistry, hematology, Coagulation
xannot-018 18 T1:r 1 Laboratory assessment including chemistry, hematology, and coagulation parameters should be performed on Days -8, -1, 8, 23, and 28 only. Chemistry, hematology, Coagulation 2 cells
xannot-019 19 T1:s 1 Menstruation check is for women only; women of childbearing potential should only be enrolled after a negative serum pregnancy test result at Screening. Additional urine pregnancy testing will be standard for the protocol unless serum testing is required by site policies, local regulation, or Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) (Section 10.2). In addition to pregnancy tests detailed at the visits in the SoA, females of childbearing potential will be required to perform urine pregnancy tests at least every 4 weeks at their home or the study site throughout their time in the study. Urine/serum pregnancy test | Urination and bowel movement monitoring, menstruation check Section 10.2
xannot-020 20 T1:t 1 A single 15 mL serum sample will be retained for evaluation in the event of an unexpected safety finding; retained samples may be destroyed after completion of the clinical study report. Retained serum sample (safety)
xannot-021 21 T1:u 1 Vital signs measurements and ECGs should be performed predose, unless otherwise specified. Vitals signs include body temperature, heart rate, respiratory rate, and systolic and diastolic blood pressure. Vitals sign measurements
xannot-022 22 T1:v 1 Copper- and molybdenum-controlled diet will be initiated after registration/inclusion. Participants will remain on a copper/molybdenum controlled diet throughout both the inpatient Period 1 (Day -8 to Day 9) and inpatient Period 2 (Day 23 to Day 40); during this time participants will be strongly encouraged to complete all meals. While not in the CRU, participants will be encouraged to adhere to their usual copper-controlled diet. Cu/Mo-controlled meals
xannot-023 23 T1:w 1 For each input/output balance period, 24-hour urine samples are to be collected for measurement of copper and molybdenum. 24-hour urine for Cu and Mo
xannot-024 24 T1:x 1 For fecal samples, each individual sample will be independently collected with record of date, time, and weight of the sample. Feces for Cu and Mo
xannot-025 25 T1:n1 1 Reviewer note, not source content: this row prints with no marks at the top of page 15. Table 2 (page 17) prints 'Blood sampling for PK: Plasma total Mo and PUF-Mo' and 'PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu' in one cell with one set of marks, so this row is probably the continuation of the PK row above (row 30, page 14), split by the page break. Not asserted: Table 2 covers only Days 1, 25, 29 and 39, so the PD sampling days are not stated for Table 1. PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu
xannot-026 26 T2:a 1 Time points are relative to dosing (0 hours). Study Phase
xannot-027 27 T2:b 1 Hour 24 PK/PD sampling is to occur just prior to the next-day dose of ALXN1840. Blood sampling for PK: Plasma total Mo and PUF-Mo | PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu 2 cells
xannot-028 28 T2:n1 1 Note: Windows for PK/PD time points will be defined as ±10% of the nominal time point. On Days 1 and 39, triplicate 12-lead ECG will be collected at 4 hours postdose. When multiple procedures are scheduled to occur at the same time, the following order of events should be strictly adhered to whenever possible: ECG, vital signs, blood sampling (eg, for PK/PD), study intervention administration, and meal. table