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Copper Chelator
Bis-Choline Tetrathiomolybdate for Wilson's Disease
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 predose up to 4 hours postdose at week 6 (day 43) and week 36 (day 253)
Awards & highlights
Study Summary
This trial will test the effectiveness and safety of ALXN1840 in adults with Wilson Disease who have been previously treated for at least one year.
Eligible Conditions
- Wilson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose up to 4 hours postdose at week 6 (day 43) and week 36 (day 253)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 4 hours postdose at week 6 (day 43) and week 36 (day 253)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Liver Cu Concentration at Week 48 (Treatment Period)
Secondary outcome measures
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)
+12 moreSide effects data
From 2023 Phase 2 trial • 31 Patients • NCT0442243126%
Alanine aminotransferase increased
26%
Gamma-glutamyltransferase increased
23%
Headache
19%
Nausea
16%
Nasopharyngitis
16%
Pyrexia
13%
Fatigue
13%
COVID-19
13%
Blood alkaline phosphatase increased
13%
Hepatic enzyme increased
10%
Arthralgia
10%
Lethargy
10%
Aspartate aminotransferase increased
10%
Blood creatine phosphokinase increased
10%
Transaminases increased
10%
Hypercholesterolaemia
10%
Rash
6%
Tremor
6%
Decreased appetite
6%
Presyncope
6%
Constipation
6%
Dizziness
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%
Diabetic foot
3%
Bacterial vaginosis
3%
Depression
3%
Bence Jones proteinuria
3%
Paraesthesia
3%
Conjunctivitis
3%
Anxiety disorder
3%
Ureteric obstruction
3%
Immunisation reaction
3%
Balance disorder
3%
Post procedural sepsis
3%
Depressed mood
3%
Dermatophytosis
3%
Furuncle
3%
Respiratory tract infection
3%
Back pain
3%
Carpal tunnel syndrome
3%
Folliculitis
3%
Acute kidney injury
3%
Haemorrhoids thrombosed
3%
Gingivitis
3%
Joint effusion
3%
Anxiety
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%
Dysmenorrhoea
3%
Haemorrhagic ovarian cyst
3%
Heavy menstrual bleeding
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
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
252 Previous Clinical Trials
41,121 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
39,246 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,392 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have enrolled in this exploration?
"This study is no longer enrolling patients, having been initially posted on December 2nd 2020 and last updated July 11th 2022. If you are interested in exploring other options for treatment, there are currently 10 clinical trials availing themselves of participants with Wilson's Disease and two studies looking to incorporate Bis-Choline Tetrathiomolybdate into their protocols."
Answered by AI
Has the Food and Drug Administration authorized Bis-Choline Tetrathiomolybdate for public use?
"Bis-Choline Tetrathiomolybdate has some data pointing to its safety; as such, it was awarded a score of 2. However, there is no evidence that this drug can effectively treat any conditions."
Answered by AI
Are there any potential participants still being considered for this clinical experiment?
"Data hosted on clinicaltrials.gov implies this trial is not currently recruiting participants. The initial posting was December 2nd 2020 and the post has been edited for the last time on July 11th 2022. Even though enrollment in this study is suspended, there are 12 other trials that remain open to applicants presently."
Answered by AI
What prior research has been done utilizing Bis-Choline Tetrathiomolybdate?
"Presently, there are two ongoing clinical trials assessing Bis-Choline Tetrathiomolybdate; neither of which have yet reached Phase 3. Notably, the majority of these studies take place in London and Texas but they are also being conducted at 12 different sites."
Answered by AI
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