Early Access Program for ALXN1840 in Patients With Wilson Disease
Study Identifier:
D9430R00001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN1840
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 3+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840.
- Confirmed diagnosis of WD.
- Has completed one of the following ALXN1840 clinical studies:
- ALXN1840-WD-205
- WTX101-301
- ALXN1840-WD-302
- Other ALXN1840 studies
- In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant.
- Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP.
- Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance.
Exclusion Criteria
- Eligible for and able to participate in an Alexion-sponsored study of ALXN1840.
- Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason.
- Has decompensated hepatic cirrhosis.
- Model for End-Stage Liver Disease (MELD) score \> 13.
- Modified Nazer Score \> 7.
- End-stage renal disease on dialysis (chronic kidney disease stage 5 \[CKD 5\]) or creatinine clearance \< 30 mL/min.
- Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840.
- Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).
Sex
Female & Male
Age
3+ years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN1840
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 3+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840.
- Confirmed diagnosis of WD.
- Has completed one of the following ALXN1840 clinical studies:
- ALXN1840-WD-205
- WTX101-301
- ALXN1840-WD-302
- Other ALXN1840 studies
- In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant.
- Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP.
- Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance.
Exclusion Criteria
- Eligible for and able to participate in an Alexion-sponsored study of ALXN1840.
- Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason.
- Has decompensated hepatic cirrhosis.
- Model for End-Stage Liver Disease (MELD) score \> 13.
- Modified Nazer Score \> 7.
- End-stage renal disease on dialysis (chronic kidney disease stage 5 \[CKD 5\]) or creatinine clearance \< 30 mL/min.
- Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840.
- Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).
Protocol Summary
This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.
Trial Locations
No locations found.