A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After… (NCT05148299) | Clinical Trial Compass
CompletedPhase 2
A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation
United States, France12 participantsStarted 2022-02-01
Plain-language summary
The purpose of the study was to assess pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety of pegcetacoplan in patients with TA-TMA after HSCT.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged ≥ 18 years at the time of informed consent form (ICF) signature.
✓. Received allogeneic HSCT.
✓. Diagnosis of TA-TMA established, as per laboratory markers indicating TMA.
✓. Have a diagnosis of TA-TMA that persists despite initial management of any triggering condition.
✓. Have random urine protein/creatinine ratio (rUPCR) ≥ 1 mg/mg.
✓. Women of childbearing potential, defined as any women who have experienced menarche and who are NOT permanently sterile or postmenopausal, must have a negative serum pregnancy test at screening and agree to use protocol-defined methods of contraception for the duration of the study and 8 weeks after their last investigational medicinal product (IMP) dose.
✓. Men must agree to the following for the duration of the study and 8 weeks after their last dose of IMP:
✓. Avoid fathering a child.
Exclusion criteria
✕. Positive direct Coombs test.
✕. Known familial or acquired ADAMTS13 deficiency.
✕. Known Shiga toxin-related hemolytic uremic syndrome.
✕. Known bone marrow or graft failure.
✕
What they're measuring
1
Pegcetacoplan Pharmacokinetic (PK) Parameter Area Under the Curve Limited to the End of Dosing Interval (AUC0-tau)