Clinical Trials Logo

Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT05686564
Other study ID # D9430R00001
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date May 2023
Source Alexion
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.


Description:

To provide access to ALXN1840 treatment, an investigational medicinal product (IMP) that has not yet been granted marketing authorization, to participants who complete Studies ALXN1840-WD-205, WTX101-301, or ALXN1840-WD-302, or other studies with ALXN1840 who, in the opinion of the Treating Physician, may benefit from continued treatment with ALXN1840, and who meet the eligibility criteria described in this protocol.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 3 Years and older
Eligibility Inclusion Criteria: 1. = 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840. 2. Confirmed diagnosis of WD. 3. Has completed one of the following ALXN1840 clinical studies: 1. ALXN1840-WD-205 2. WTX101-301 3. ALXN1840-WD-302 4. Other ALXN1840 studies 4. In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant. 5. Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP. 6. Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance. Exclusion Criteria: 1. Eligible for and able to participate in an Alexion-sponsored study of ALXN1840. 2. Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason. 3. Has decompensated hepatic cirrhosis. 4. Model for End-Stage Liver Disease (MELD) score > 13. 5. Modified Nazer Score > 7. 6. End-stage renal disease on dialysis (chronic kidney disease stage 5 [CKD 5]) or creatinine clearance < 30 mL/min. 7. Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840. 8. Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ALXN1840
bis-choline tetrathiomolybdate

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alexion
See also
  Status Clinical Trial Phase
Completed NCT04573309 - Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 Phase 2
Completed NCT03539952 - Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease Phase 3
Active, not recruiting NCT04884815 - Study of UX701 Gene Transfer for the Treatment of Wilson Disease Phase 1/Phase 2
Not yet recruiting NCT03659331 - A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease N/A
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Completed NCT04965571 - Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Terminated NCT05047523 - Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease Phase 3
Completed NCT04526210 - Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants Phase 1
Completed NCT00004338 - Study of Zinc for Wilson Disease Phase 4
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Completed NCT02273596 - Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients Phase 2
Completed NCT02763215 - The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
Recruiting NCT05444127 - Oral Health and Wilson's Disease: SOMAWI
Completed NCT04408300 - Study of Retinal Vascular Parameters in Patients With Wilson's Disease N/A
Active, not recruiting NCT05783687 - Real World Evidence Study in Subjects With Wilson's Disease
Terminated NCT04909346 - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed NCT03867526 - Establishment of Human Cellular Disease Models for Wilson Disease
Enrolling by invitation NCT03589820 - Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure N/A
Completed NCT04526197 - Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants. Phase 1
Not yet recruiting NCT06430359 - Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients