A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation
Part of paid clinical trials in Duarte, California.
- Sponsor
- Swedish Orphan Biovitrum
- Study ID
- NCT05148299
- Phase
- PHASE2
- Status
- Completed
Conditions
- Transplant-Associated Thrombotic Microangiopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pegcetacoplan — DRUG20-cc glass vials-1080 mg
Study Details
The purpose of the study was to assess pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety of pegcetacoplan in patients with TA-TMA after HSCT.
Key Dates
- Start date
- Feb 1, 2022
- Status verified
- Sep 2025
- Primary completion
- Dec 8, 2024
- Completion
- Dec 8, 2024
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Pegcetacoplansterile solution in stoppered glass vial given as infusion, for a total treatment duration of 12 to 16 weeks.
Primary Outcome Measure
Pegcetacoplan Pharmacokinetic (PK) Parameter Area Under the Curve Limited to the End of Dosing Interval (AUC0-tau) [ Time Frame: Week 1 ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | - |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | - |
Related coverage on Hipa.ai
- Pegcetacoplan Trial Results Posted for TA-TMA: PK Parameters DetailedPegcetacoplan · Nov 28, 2025 · ClinicalTrials.gov
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