Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Study Identifier:
ALXN1210-aHUS-311
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
- Atypical Hemolytic Uremic Syndrome (aHUS)
Study Drug
- Biological: Ravulizumab
Date
Jan 2017 - Jan 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female ≥ 12 years of age and weighing ≥ 40 kg at the time of consent.
- Evidence of thrombotic microangiopathy, including low platelet count, hemolysis (breaking of red blood cells inside of blood vessels), and decreased kidney function.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study drug. Participants who received a meningococcal vaccine less than 2 weeks before initiating ravulizumab treatment must have received treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Participants who had not been vaccinated prior to initiating ravulizumab treatment should have received prophylactic antibiotics prior to and for at least 2 weeks after meningococcal vaccination. Participants \< 18 years of age must have been vaccinated against haemophilus influenzae type b and streptococcus pneumoniae according to national and local vaccination schedule guidelines.
- Female participants of childbearing potential and male participants with female partners of childbearing potential had to use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
Exclusion Criteria
- A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 deficiency (activity \< 5%).
- Shiga toxin-related hemolytic uremic syndrome.
- Positive direct Coombs test.
- Pregnancy or breastfeeding.
- Identified drug exposure-related hemolytic uremic syndrome (HUS).
- Bone marrow transplant/hematopoietic stem cell transplant within last 6 months prior to start of Screening.
- HUS related to known genetic defects of cobalamin C metabolism.
- Systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome.
- Chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end-stage kidney disease).
Sex
Female & Male
Age
N/A
Study Details
Medical Condition
- Atypical Hemolytic Uremic Syndrome (aHUS)
Study Drug
- Biological: Ravulizumab
Date
Jan 2017 - Jan 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female ≥ 12 years of age and weighing ≥ 40 kg at the time of consent.
- Evidence of thrombotic microangiopathy, including low platelet count, hemolysis (breaking of red blood cells inside of blood vessels), and decreased kidney function.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study drug. Participants who received a meningococcal vaccine less than 2 weeks before initiating ravulizumab treatment must have received treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Participants who had not been vaccinated prior to initiating ravulizumab treatment should have received prophylactic antibiotics prior to and for at least 2 weeks after meningococcal vaccination. Participants \< 18 years of age must have been vaccinated against haemophilus influenzae type b and streptococcus pneumoniae according to national and local vaccination schedule guidelines.
- Female participants of childbearing potential and male participants with female partners of childbearing potential had to use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
Exclusion Criteria
- A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 deficiency (activity \< 5%).
- Shiga toxin-related hemolytic uremic syndrome.
- Positive direct Coombs test.
- Pregnancy or breastfeeding.
- Identified drug exposure-related hemolytic uremic syndrome (HUS).
- Bone marrow transplant/hematopoietic stem cell transplant within last 6 months prior to start of Screening.
- HUS related to known genetic defects of cobalamin C metabolism.
- Systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome.
- Chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end-stage kidney disease).
Protocol Summary
The purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with aHUS who had not previously used a complement inhibitor.
Trial Locations
Location
Status
Location
Clinical Trial Site
Fort Wayne, Indiana, United States, 46804
Status
N/A
Location
Clinical Trial Site
Fort Wayne, Indiana, United States, 46845
Status
N/A
Location
Clinical Trial Site
Durham, North Carolina, United States, 27705
Status
N/A
Location
Clinical Trial Site
Winston-Salem, North Carolina, United States, 27103
Status
N/A
Location
Clinical Trial Site
Columbus, Ohio, United States, 43210
Status
N/A
Location
Clinical Trial Site
Clayton, Australia
Status
N/A
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