drugset / Trial / NCT03403205
Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2018-02-22
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TIOMOLIBDATE CHOLINE | Small molecule | 15 mg | Oral |
| Subject | TIOMOLIBDATE CHOLINE | Small molecule | 60 mg | Oral |
| Comparator | Zinc Sulfate | Unknown | — | — |
| Comparator | penicillamine | Unknown | — | — |
| Comparator | trientine | Unknown | — | — |