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Bis-Choline Tetrathiomolybdate

Phase 2

Wilson Disease | Small molecule | Rare Disease |AstraZeneca PLC|Last Updated: Oct 18, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Bis-Choline Tetrathiomolybdate · 1 trial · 1 indication

Phase 2 1
NCT04422431Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840Wilson Disease
COMPLETED31 Analytics
PHASE2COMPLETED
Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
Wilson Disease
NCT0442243131
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Study Endpoints

Primary Endpoints

Change From Baseline in Liver Cu Concentration at Week 48 (Treatment Period)
Baseline, Week 48 (Treatment Period)

Liver biopsy samples were taken for the assessment of liver Cu concentration. Multiple imputation was used to impute missing data at Week 48 due to any reason based on Baseline values.

Secondary Endpoints

Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline, Week 48 (Treatment Period)
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Baseline, Week 48 (Treatment Period)
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline, Week 48 (Treatment Period)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALXN1840EXPERIMENTALParticipants will receive ALXN1840.

Interventions

NameTypeDescription
Bis-Choline TetrathiomolybdateDRUGParticipants will be initiated at 15 milligrams once daily, then the dose will be increased to 30 milligrams once daily at Week 6.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. Diagnosis of WD by Leipzig Criteria ≥ 4 or by historical test results. 2. Continuous treatment for WD with penicillamine, trientine or zinc for at least 1 year prior to screening. 3. Body mass index \< 30 kilograms/meter squared. 4. Able to cooperate with a percutaneous liver...

Countries:United StatesCanadaDenmarkNew ZealandRussiaSingaporeSpainUnited Kingdom
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Frequently asked questions about Bis-Choline Tetrathiomolybdate

What is Bis-Choline Tetrathiomolybdate used for?

Bis-Choline Tetrathiomolybdate is an investigational small molecule being developed for the treatment of Wilson Disease, a rare genetic disorder of copper metabolism. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Bis-Choline Tetrathiomolybdate?

Bis-Choline Tetrathiomolybdate is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is in Phase 2 clinical development for Wilson Disease.

What phase is Bis-Choline Tetrathiomolybdate in?

Bis-Choline Tetrathiomolybdate is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. A Phase 2 clinical trial for Wilson Disease has been completed.

What clinical trials is Bis-Choline Tetrathiomolybdate in?

Bis-Choline Tetrathiomolybdate has one completed Phase 2 clinical trial, identified as NCT04422431. This trial, titled 'Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840,' enrolled 31 participants across multiple countries including the United States, Canada, Denmark, New Zealand, Russia, Singapore, Spain, and the United Kingdom.

Is Bis-Choline Tetrathiomolybdate the same as ALXN1840?

Yes, Bis-Choline Tetrathiomolybdate is also known as ALXN1840. The completed Phase 2 clinical trial NCT04422431 for Wilson Disease used the name ALXN1840 in its title, confirming that these names refer to the same investigational drug.