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Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

Primary Purpose

Wilson Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ALXN1840

SoC Therapy

About this trial

This is an interventional treatment trial for Wilson Disease focused on measuring Wilson Disease, ALXN1840, Copper

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Established diagnosis of WD by Leipzig-Score ≥ than 4
Female participants of childbearing potential, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception starting at least 6 weeks before the Day 1 visit and continuing through 28 days after the last dose of either ALXN1840 or SoC
Male participants, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception beginning at Day 1 visit and continuing through 90 days after last dose of either ALXN1840 or SoC

Key Exclusion Criteria:

Decompensated hepatic cirrhosis
MELD score > 13
Modified Nazer score > 7
Clinically significant gastrointestinal bleed within past 3 months
Alanine aminotransferase > 2 X upper limit of normal (ULN) for participants treated for > 28 days with WD therapy (Cohort 1)
Alanine aminotransferase > 5 X ULN for treatment-naïve participants or participants who have been treated for ≤ 28 days (Cohort 2)
Marked neurological disease requiring either nasogastric feeding or intensive inpatient medical care
Hemoglobin < 9 grams/deciliter
History of seizure activity within 6 months prior to informed consent
Pregnant (or women who are planning to become pregnant) or breastfeeding women
Active infection with hepatitis B virus (positive hepatitis B surface antigen) or C virus or seropositivity for human immunodeficiency virus (HIV)
Previous treatment with tetrathiomolybdate
Participants with end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance < 30 milliliter/minute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALXN1840

Standard of Care (SoC) Medication

Arm Description

ALXN1840 was administered orally for 48 weeks at doses ranging from 15 milligrams (mg) every other day (QOD) up to a titrated dose of 60 mg daily. Participants who completed the Primary Evaluation Period had the option to participate in the up to 60-month Extension Period.

SoC medication was administered for 48 weeks. Participants who completed the Primary Evaluation Period had the option to participate in the up to 60-month Extension Period.

Outcomes

Primary Outcome Measures

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)

dNCC is the directly quantified copper not bound to ceruloplasmin, obtained by inductively coupled plasma mass spectrometry after immunocapture and removal of ceruloplasmin. Baseline was defined as last non-missing value on or before first study drug administration. Least square (LS) mean and standard error (SE) was calculated using analysis of covariance (ANCOVA).

Secondary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. TEAEs were defined as those AEs with onset after the first dose of randomized treatment or existing events that worsened in severity after the first dose of randomized treatment. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Change From Baseline in the Unified Wilson Disease Rating Scale (UWDRS) Part II Total Score at Week 48

The UWDRS is a clinical rating scale designed to evaluate the neurological manifestations of Wilson Disease (WD). The UWDRS comprises 3 parts: UWDRS Part I (level of consciousness, item 1), UWDRS Part II (a patient-reported review of daily activity items [disability], items 2 to 11 [10 items in total]), and UWDRS Part III (a detailed neurological examination, items 12 to 34 [23 items in total]). The UWDRS Part II may be reported to a non-blinded member of the study team, by the participant, family member or caregiver. The UWDRS Part II total score was calculated as the sum of Question 2 to Question 11 (each question has range 0 [none] to 4 [severe]). The UWDRS Part II total score ranges from 0 (no disability) to 40 (severe disability), with lower score indicating improvement in condition and a better outcome. Change from baseline was calculated as: postbaseline assessment value - baseline assessment value when both values were not missing.

Change From Baseline in UWDRS Part III Total Score at Week 48

The UWDRS is a clinical rating scale designed to evaluate the neurological manifestations of Wilson Disease (WD). The UWDRS comprises 3 parts: UWDRS Part I (level of consciousness, item 1), UWDRS Part II (a patient-reported review of daily activity items [disability], items 2 to 11 [10 items in total]), and UWDRS Part III (a detailed neurological examination, items 12 to 34 [23 items in total]). The UWDRS Part I and III was assessed by a neurologist who was blinded to the treatment randomization. The UWDRS Part III total score was calculated as the sum of Question 12 to Question 34. The UWDRS Part III total score ranges from 0 (normal) to 175 (severe disease), with lower score indicating improvement in condition and a better outcome. Change from baseline was calculated as: postbaseline assessment value - baseline assessment value when both values were not missing.

Change From Baseline in UWDRS Part III Functional Subscale Score at Week 48

UWDRS Part III Functional Subscale consists of speech, handwriting, arising from chair, and gait from UWDRS Part III. The standardized score of the first 3 items ranges from 0 (normal) to 10 (worst), and standardized transformed score of gait ranges from 0 (normal) to 10 (worst). The average of these scores was used to create the Part III Functional Subscale with a range of 0 (normal) - 10 (worst) with higher scores indicating more functional disability.

Change From Baseline in UWDRS Part III Individual Items/Subscales (Speech, Handwriting, Arising From a Chair, and Gait) Score at Week 48

UWDRS Part III individual items speech, handwriting, arising from chair, and gait are reported here. For speech (Question 12), original score ranges from 0 (normal) to 4 (unintelligible). For handwriting (Question 20), original score ranges from 0 (normal) to 4 (cannot hold a pen). For arising from chair (Question 27), original score ranges from 0 (normal) to 4 (unable to arise without help). For gait (Question 29), the original score (range: 0 [normal] to 10 [severe condition]) was calculated by summing subscores (0 [normal] to 4 [severe]) of Part A (Right and Left Leg dystonia), B (Ataxia), and C (Parkinsonism).

Clinical Global Impression-Improvement Scale (CGI-I) Score at Week 48

The CGI-I is a 7-point scale where the clinician assessed how much participant's illness improved or worsened relative to a Baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Week 48

The CGI-S is a 7-point scale where the investigator rated severity of participant's illness at the time of assessment, relative to the investigator's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant was assessed on severity of illness at time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.

Change From Baseline in Model for End-Stage Liver Disease (MELD) Score at Week 48

The MELD is a scoring system for assessing the severity of chronic liver disease in participants 12 years and older. The MELD score uses the participant's values for bilirubin, creatinine, and the international normalized ratio (INR). The initial MELD score (MELD[i]) is calculated according to the following formula: MELD(i) = 3.78*ln[serum bilirubin (mg/dL)] + 11.2*ln[INR] + 9.57*ln[serum creatinine (mg/dL)] + 6.43. Creatinine, bilirubin, and INR values less than 1.0 are set to 1.0 and creatinine values greater than 4.0 are set to 4.0 when calculating MELD(i). Additionally, creatinine, bilirubin, and INR are rounded to the 10th decimal place prior to performing the calculation. The initial MELD score is then rounded to the nearest integer. The MELD score ranges from 6 (least sick) - 40 (most sick), with higher values indicating more advanced disease.

Absolute Change From Baseline in Calculated Non-Ceruloplasmin Bound Copper (cNCC) or Calculated Non-Ceruloplasmin Bound Copper Corrected (cNCCcorrected) in Plasma at Week 48

cNCC [µmol/L] = Plasma Total Copper (Cu) [micrograms (µg)/L]-(3.15*ceruloplasmin [milligrams (mg)/L])/63.5 [µg/µmol] For ALXN1840-treated participants, cNCC in plasma was corrected for the amount of Cu bound to ALXN1840 tripartite complex (TPC) using square root-based cNCC correction method (cNCCcorrected): cNCCcorrected = (√cNCC- 0.993)2√Mo, (Mo= molybdenum). In calculation of cNCC and cNCCcorrected following rules apply: For plasma total Cu concentration values <lower limit of quantification (LLOQ), cNCC was considered missing (LLOQ value of plasma total Cu= 20 nanograms [ng]/mL); Serum ceruloplasmin concentration values <LLOQ are set to 0 (LLOQ value of serum ceruloplasmin= 22.5 mg/L); Plasma total Mo concentration values <LLOQ are set to 0 (LLOQ value of plasma total Mo= 1 ng/L); In cases where cNCC calculation produces a negative result, cNCC was considered missing and cNCCcorrected was not derived; cNCCcorrected was set to 0 when 0.993√Mo > √cNCC.

Percent Change From Baseline in cNCC or cNCCcorrected in Plasma at Week 48

cNCC was calculated as follows: cNCC [µmol/L] = Plasma Total Cu [µg/L]-(3.15*ceruloplasmin [mg/L])/63.5 [µg/µmol] For ALXN1840-treated participants, the cNCC in plasma was corrected for the amount of Cu bound to the ALXN1840 TPC using the square root-based cNCC correction method (cNCCcorrected) as follows: cNCCcorrected = (√cNCC- 0.993)2√Mo, where Mo = molybdenum. In the calculation of cNCC and cNCCcorrected the following rules apply: For plasma total Cu concentration values < LLOQ, cNCC was considered missing (LLOQ value of plasma total Cu = 20 ng/mL); Serum ceruloplasmin concentration values <LLOQ are set to 0 (LLOQ value of serum ceruloplasmin = 22.5 mg/L); Plasma total Mo concentration values <LLOQ are set to 0 (LLOQ value of plasma total Mo = 1 ng/L); In cases where cNCC calculation produces a negative result, cNCC was considered missing and cNCCcorrected was not derived; cNCCcorrected was set to 0 when 0.993√Mo > √cNCC.

cNCC/cNCCcorrected Responder at Week 48

cNCC/cNCCcorrected responder was defined as participants who achieved or maintained normalized cNCC/cNCCcorrected concentration (0.8-2.3 μmol) within (at or before) 48 weeks or reached a reduction of at least 25% in cNCC/cNCCcorrected within 48 weeks. Thus, a participant was considered a cNCC/cNCCcorrected responder if they met at least 1 of the following criteria: Achieved normalized cNCC/cNCCcorrected concentration for 2 consecutive measurements within 48 weeks, for participants who had elevated cNCC concentrations at baseline; Maintained normalized cNCC/cNCCcorrected concentration within 48 weeks, for participants who had normal cNCC concentrations at baseline; Reached a reduction of at least 25% in cNCC/cNCCcorrected for 2 consecutive measurements within 48 weeks.

Full Information

NCT ID

NCT03403205

First Posted

December 19, 2017

Last Updated

September 13, 2023

Sponsor

Alexion

1. Study Identification

Unique Protocol Identification Number

NCT03403205

Brief Title

Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

Official Title

A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to terminate the program

Study Start Date

February 15, 2018 (Actual)

Primary Completion Date

February 24, 2021 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

Detailed Description

The study consists of 2 cohorts. Cohort 1: Participants who have received SoC therapy for > 28 days and Cohort 2: Participants who are treatment-naïve or who have received SoC therapy for ≤ 28 days. All enrolled participants were randomized by cohort in a 2:1 ratio to treatment with ALXN1840 or SoC (either as continued therapy in Cohort 1 or as continued or initial therapy in Cohort 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wilson Disease

Keywords

Wilson Disease, ALXN1840, Copper

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

This study is rater-blinded for the Unified Wilson Disease Rating Scale (UWDRS) assessment only.

Allocation

Randomized

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALXN1840

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care (SoC) Medication

Arm Type

Active Comparator

Arm Description

SoC medication was administered for 48 weeks. Participants who completed the Primary Evaluation Period had the option to participate in the up to 60-month Extension Period.

Intervention Type

Drug

Intervention Name(s)

ALXN1840

Other Intervention Name(s)

Formerly named WTX101, Tiomolibdic acid, Tiomolibdate choline, Bis-choline tetrathiomolybdate

Intervention Description

ALXN1840 administered orally in 15 mg tablets

Intervention Type

Drug

Intervention Name(s)

SoC Therapy

Intervention Description

Depending on the site/region, participants randomized to receive SoC treatment will receive trientine, penicillamine, Zinc, or a combination of these medicines, administered according to standard regimens.

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

Baseline to Week 48

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

Baseline up to Week 48

Title

Change From Baseline in the Unified Wilson Disease Rating Scale (UWDRS) Part II Total Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Change From Baseline in UWDRS Part III Total Score at Week 48

Description

The UWDRS is a clinical rating scale designed to evaluate the neurological manifestations of Wilson Disease (WD). The UWDRS comprises 3 parts: UWDRS Part I (level of consciousness, item 1), UWDRS Part II (a patient-reported review of daily activity items [disability], items 2 to 11 [10 items in total]), and UWDRS Part III (a detailed neurological examination, items 12 to 34 [23 items in total]). The UWDRS Part I and III was assessed by a neurologist who was blinded to the treatment randomization. The UWDRS Part III total score was calculated as the sum of Question 12 to Question 34. The UWDRS Part III total score ranges from 0 (normal) to 175 (severe disease), with lower score indicating improvement in condition and a better outcome. Change from baseline was calculated as: postbaseline assessment value - baseline assessment value when both values were not missing.

Time Frame

Baseline, Week 48

Title

Change From Baseline in UWDRS Part III Functional Subscale Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Change From Baseline in UWDRS Part III Individual Items/Subscales (Speech, Handwriting, Arising From a Chair, and Gait) Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Clinical Global Impression-Improvement Scale (CGI-I) Score at Week 48

Description

Time Frame

Week 48

Title

Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Change From Baseline in Model for End-Stage Liver Disease (MELD) Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Absolute Change From Baseline in Calculated Non-Ceruloplasmin Bound Copper (cNCC) or Calculated Non-Ceruloplasmin Bound Copper Corrected (cNCCcorrected) in Plasma at Week 48

Description

Time Frame

Baseline, Week 48

Title

Percent Change From Baseline in cNCC or cNCCcorrected in Plasma at Week 48

Description

Time Frame

Baseline, Week 48

Title

cNCC/cNCCcorrected Responder at Week 48

Description

Time Frame

Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Established diagnosis of WD by Leipzig-Score ≥ 4 Female participants of childbearing potential, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception starting at least 6 weeks before the Day 1 visit and continuing through 28 days after the last dose of either ALXN1840 or SoC Male participants, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception beginning at Day 1 visit and continuing through 90 days after last dose of either ALXN1840 or SoC Key Exclusion Criteria: Decompensated hepatic cirrhosis MELD score > 13 Modified Nazer score > 7 Clinically significant gastrointestinal bleed within past 3 months Alanine aminotransferase > 2 X upper limit of normal (ULN) for participants treated for > 28 days with WD therapy (Cohort 1) Alanine aminotransferase > 5 X ULN for treatment-naïve participants or participants who have been treated for ≤ 28 days (Cohort 2) Marked neurological disease requiring either nasogastric feeding or intensive inpatient medical care Hemoglobin < 9 grams/deciliter History of seizure activity within 6 months prior to informed consent Pregnant (or women who are planning to become pregnant) or breastfeeding women Active infection with hepatitis B virus (positive hepatitis B surface antigen) or C virus or seropositivity for human immunodeficiency virus (HIV) Previous treatment with tetrathiomolybdate Participants with end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance < 30 milliliter/minute

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugene S. Swenson, M.D., Ph.D.

Organizational Affiliation

Alexion

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Trial Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Clinical Trial Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Clinical Trial Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Clinical Trial Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Clinical Trial Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Clinical Trial Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98145

Country

United States

Facility Name

Clinical Trial Site

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

Clinical Trial Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Clinical Trial Site

City

Graz

State/Province

Styria

ZIP/Postal Code

8036

Country

Austria

Facility Name

Clinical Trial Site

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Clinical Trial Site

City

Wien

State/Province

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Clinical Trial Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Clinical Trial Site

City

Prague

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Clinical Trial Site

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Clinical Trial Site

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

Clinical Trial Site

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

Clinical Trial Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Clinical Trial Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Clinical Trial Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Clinical Trial Site

City

Hong Kong

ZIP/Postal Code

852

Country

Hong Kong

Facility Name

Clinical Trial Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Clinical Trial Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Clinical Trial Site

City

Tel-Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Clinical Trial Site

City

Chiba-Shi

State/Province

Chiba

ZIP/Postal Code

266-0007

Country

Japan

Facility Name

Clinical Trial Site

City

Matsuyama-Shi

State/Province

Ehime

ZIP/Postal Code

790-0024

Country

Japan

Facility Name

Clinical Trial Site

City

Kurume-Shi

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Clinical Trial Site

City

Sapporo-Shi

State/Province

Hokkaido

ZIP/Postal Code

063-0005

Country

Japan

Facility Name

Clinical Trial Site

City

Yokohama-Shi

State/Province

Kanagawa

ZIP/Postal Code

230-8765

Country

Japan

Facility Name

Clinical Trial Site

City

Takatsuki-Shi

State/Province

Osaka

ZIP/Postal Code

569-8686

Country

Japan

Facility Name

Clinical Trial Site

City

Meguro-Ku

State/Province

Tokyo

ZIP/Postal Code

153-8515

Country

Japan

Facility Name

Clinical Trial Site

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Clinical Trial Site

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

Clinical Trial Site

City

Warszawa

State/Province

Woj. Mazowieckie

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Clinical Trial Site

City

Warszawa

ZIP/Postal Code

02-957

Country

Poland

Facility Name

Clinical Trial Site

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

Clinical Trial Site

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Clinical Trial Site

City

Nizhny Novgorod

ZIP/Postal Code

603950

Country

Russian Federation

Facility Name

Clinical Trial Site

City

Saint Petersburg

ZIP/Postal Code

194017

Country

Russian Federation

Facility Name

Clinical Trial Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Trial Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Clinical Trial Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Clinical Trial Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Clinical Trial Site

City

Málaga

ZIP/Postal Code

29011

Country

Spain

Facility Name

Clinical Trial Site

City

Taoyuan City

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Clinical Trial Site

City

Istanbul

ZIP/Postal Code

34010

Country

Turkey

Facility Name

Clinical Trial Site

City

Istanbul

ZIP/Postal Code

34104

Country

Turkey

Facility Name

Clinical Trial Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Clinical Trial Site

City

Birmingham

State/Province

England

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Guildford

State/Province

England

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Clinical Trial Site

City

London

State/Province

England

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Learn more about this trial

Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

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Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

Wilson Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial