Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
Study Identifier:
ALXN1840-WD-204
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN1840
Date
Sep 2020 - Jun 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosis of WD by Leipzig Criteria ≥ 4.
- Able to reside in the clinical research unit for intensive metabolic monitoring of copper and molybdenum.
- Participants willing to adhere to copper/molybdenum-controlled diet during the study.
- Willing and able to follow protocol-specified contraception requirements.
- Capable of giving signed informed consent.
Exclusion Criteria
- Decompensated cirrhosis or model for end stage liver disease score \> 13.
- Modified Nazer score \> 7.
- Clinically significant gastrointestinal bleed within past 3 months.
- Alanine aminotransferase \> 2 × upper limit of normal.
- Hemoglobin less than lower limit of the reference range for age and sex.
- Significant medical history (current or past).
- Previous treatment with zinc within 30 days prior to the Screening Visit.
- Participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance \< 30 milliliters/minute.
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN1840
Date
Sep 2020 - Jun 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosis of WD by Leipzig Criteria ≥ 4.
- Able to reside in the clinical research unit for intensive metabolic monitoring of copper and molybdenum.
- Participants willing to adhere to copper/molybdenum-controlled diet during the study.
- Willing and able to follow protocol-specified contraception requirements.
- Capable of giving signed informed consent.
Exclusion Criteria
- Decompensated cirrhosis or model for end stage liver disease score \> 13.
- Modified Nazer score \> 7.
- Clinically significant gastrointestinal bleed within past 3 months.
- Alanine aminotransferase \> 2 × upper limit of normal.
- Hemoglobin less than lower limit of the reference range for age and sex.
- Significant medical history (current or past).
- Previous treatment with zinc within 30 days prior to the Screening Visit.
- Participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance \< 30 milliliters/minute.
Protocol Summary
This exploratory study will investigate the effects of ALXN1840 on copper balance in participants with Wilson disease (WD).
Trial Locations
Location
Status
Location
Research Site
New Haven, Connecticut, United States, 06510
Status
N/A
Location
Research Site
Grafton, New Zealand, 1010
Status
N/A
Location
Research Site
London, United Kingdom, SE1 1YR
Status
N/A