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Chelating Agent

ALXN1840 for Wilson's Disease

Phase 3

Waitlist Available

Research Sponsored by Alexion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

Study Summary

This trial will test a new treatment for Wilson Disease, comparing it to the current standard of care. The trial will last 48 weeks, with an optional 60-month extension period.

Eligible Conditions

Wilson's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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)

Secondary outcome measures

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

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

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

+8 more

Side effects data

From 2018 Phase 2 trial • 29 Patients • NCT02273596

36%

Alanine aminotransferase increased

32%

Aspartate aminotransferase increased

29%

Urinary tract infection

29%

Gamma-glutamyltransferase increased

21%

Fatigue

21%

Headache

21%

Hepatic enzyme increased

18%

Tremor

14%

Rash

14%

Constipation

14%

Back pain

11%

Sinusitis

11%

Blood alkaline phosphatase increased

11%

Depression

11%

Insomnia

11%

Sleep disorder

11%

Arthralgia

11%

Leukopenia

11%

Anxiety

11%

Cough

11%

Diarrhoea

Pain in extremity

Plantar fasciitis

Nausea

Blood creatine phosphokinase increased

Liver function test increased

Decreased appetite

Dupuytren's contracture

Muscle spasms

Depressed mood

Dry skin

Neck pain

Vomiting

Fall

Erythema

Tonsillitis

Upper respiratory tract infection

Influenza

Myalgia

Dysgeusia

Paraesthesia

Abnormal behaviour

Psychotic disorder

Agranulocytosis

Gait disturbance

Dysphagia

Affective disorder

Mania

Hepato-lenticular degeneration

Neurological decompensation

Neutropenia

Adjustment disorder

Personality disorder

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

ALXN1840

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ALXN1840Experimental Treatment1 Intervention

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.

Group II: Standard of Care (SoC) MedicationActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALXN1840

2020

Completed Phase 2

~340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor

246 Previous Clinical Trials

39,048 Total Patients Enrolled

Alexion PharmaceuticalsLead Sponsor

230 Previous Clinical Trials

37,194 Total Patients Enrolled

Alexion Pharmaceuticals, Inc.Lead Sponsor

252 Previous Clinical Trials

40,923 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me how many hospitals are testing this procedure?

"In addition to Children's Hospital of Philadelphia in Los Angeles, California, Texas Children's Hospital in Philadelphia, Pennsylvania, and Yale University School of Medicine in Nashville, Tennessee, this study is also enrolling at 20 other locations."

Answered by AI