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Copper Chelator

Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840

Phase 2
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (extension period) up week 52 (extension period)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new medication called ALXN1840 to help reduce liver copper levels in adults with Wilson Disease who have already been on standard treatments for a significant period. The medication works by binding to excess copper and helping the body remove it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (extension period) up week 52 (extension period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (extension period) up week 52 (extension period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Liver Cu Concentration at Week 48 (Treatment Period)
Secondary study objectives
Change From Baseline in CGI-S Scale Score at Week 48 (Treatment Period)
Change From Baseline in Hepatic Collagen Content at Week 48 (Treatment Period)
Change From Baseline in Hepatic Fat Content at Week 48 (Treatment Period)
+9 more

Side effects data

From 2023 Phase 2 trial • 31 Patients • NCT04422431
26%
Gamma-glutamyltransferase increased
26%
Alanine aminotransferase increased
23%
Headache
19%
Nausea
16%
Nasopharyngitis
16%
Pyrexia
13%
Fatigue
13%
COVID-19
13%
Blood alkaline phosphatase increased
13%
Hepatic enzyme increased
10%
Lethargy
10%
Arthralgia
10%
Aspartate aminotransferase increased
10%
Blood creatine phosphokinase increased
10%
Transaminases increased
10%
Hypercholesterolaemia
10%
Rash
9%
Dysmenorrhoea
9%
Haemorrhagic ovarian cyst
9%
Heavy menstrual bleeding
6%
Decreased appetite
6%
Dizziness
6%
Tremor
6%
Presyncope
6%
Constipation
6%
Tinnitus
6%
Diarrhoea
6%
Oral pain
6%
Asthenia
6%
Chills
6%
Feeling abnormal
6%
Hypertransaminasaemia
6%
Seasonal allergy
6%
Kidney infection
6%
Pneumonia
6%
Blood bilirubin increased
6%
Liver function test increased
6%
Upper respiratory tract infection
6%
Urinary tract infection
6%
Abdominal discomfort
6%
Abdominal pain
3%
Carpal tunnel syndrome
3%
Conjunctivitis
3%
Respiratory tract infection
3%
Acute kidney injury
3%
Haemorrhoids thrombosed
3%
Paraesthesia
3%
Anxiety
3%
Diabetic foot
3%
Anxiety disorder
3%
Bacterial vaginosis
3%
Folliculitis
3%
Joint effusion
3%
Immunisation reaction
3%
Gingivitis
3%
Balance disorder
3%
Depressed mood
3%
Furuncle
3%
Post procedural sepsis
3%
Depression
3%
Dermatophytosis
3%
Back pain
3%
Bence Jones proteinuria
3%
Ureteric obstruction
3%
Urobilinogen urine increased
3%
Leukopenia
3%
Neutropenia
3%
Thrombocytopenia
3%
Chalazion
3%
Vision blurred
3%
Vitreous detachment
3%
Abdominal pain upper
3%
Flatulence
3%
Gastrooesophageal reflux disease
3%
Mouth ulceration
3%
Toothache
3%
Vomiting
3%
Generalised oedema
3%
Pain
3%
Respiratory tract infection viral
3%
Sinusitis
3%
Fall
3%
Head injury
3%
Incision site pain
3%
Ligament sprain
3%
Post procedural haematuria
3%
Post procedural hypotension
3%
Post procedural swelling
3%
Upper limb fracture
3%
Alanine aminotransferase abnormal
3%
Blood albumin decreased
3%
Creatinine renal clearance decreased
3%
Prothrombin time prolonged
3%
Weight decreased
3%
Weight increased
3%
White blood cell count decreased
3%
Muscle spasms
3%
Glycosuria
3%
Proteinuria
3%
Breast mass
3%
Breast tenderness
3%
Asthma
3%
Chronic obstructive pulmonary disease
3%
Cough
3%
Idiopathic guttate hypomelanosis
3%
Deep vein thrombosis
3%
Blood folate decreased
3%
Insomnia
3%
Prostatitis
3%
Dry mouth
3%
Dyspepsia
3%
Faeces discoloured
3%
Temperature intolerance
3%
Post procedural fever
3%
Post vaccination syndrome
3%
Procedural pain
3%
Road traffic accident
3%
Creatinine renal clearance increased
3%
Protein urine present
3%
Diabetes mellitus
3%
Dyslipidaemia
3%
Hyperglycaemia
3%
Hypertriglyceridaemia
3%
Hyponatraemia
3%
Iron deficiency
3%
Greater trochanteric pain syndrome
3%
Myalgia
3%
Seborrhoeic keratosis
3%
Personality disorder
3%
Dyspnoea
3%
Nasal congestion
3%
Respiratory disorder
3%
Rhinorrhoea
3%
Pruritus
3%
Drug-induced liver injury
3%
Haemorrhoids
3%
Helicobacter infection
3%
Lower respiratory tract infection
3%
Paronychia
3%
Skin papilloma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Period: ALXN1840
Extension Period: ALXN1840

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALXN1840Experimental Treatment1 Intervention
Participants will receive ALXN1840.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bis-Choline Tetrathiomolybdate
2020
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
261 Previous Clinical Trials
140,453 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
38,486 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,572 Total Patients Enrolled
Eugene S. Swenson, MD, PhDStudy DirectorAlexion Pharmaceuticals, Inc.
5 Previous Clinical Trials
171 Total Patients Enrolled
~6 spots leftby Dec 2025
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