Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger (NCT04743804) | Clinical Trial Compass
TerminatedPhase 3
Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
Stopped: Recruitment Challenges
United States16 participantsStarted 2021-06-29
Plain-language summary
This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older
✓. Body weight ≥ 30 kilograms
✓. Female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab
✓. TMA associated with a trigger (autoimmune disease, infection, solid organ transplant, drugs, and malignant hypertension)
✓. Vaccinated against meningococcal infection (Neisseria meningitidis), within 3 years prior to, or at the time of, randomization. Participants who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive appropriate prophylactic antibiotics for at least 2 weeks after the vaccination. If participant cannot receive the meningococcal vaccine, then participant must be willing to receive antibiotic prophylaxis coverage against N. meningitidis during the entire Treatment Period and for 8 months following the final dose of study drug. Additional vaccination (Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae) may be considered based on individual patient condition.
Exclusion criteria
✕. Any known gene mutation that causes atypical hemolytic uremic syndrome (aHUS)
What they're measuring
1
Number of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
✕. TMA due to hematopoietic stem cell transplantation ≤ 12 months of Screening
✕. Primary and secondary glomerular diseases other than lupus
✕. Diagnosis of primary antiphospholipid antibody syndrome
✕. Shiga toxin-producing Escherichia coli infections including but not limited to Shiga toxin-related hemolytic uremic syndrome
✕. Known familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity \< 5%)