A Study Of Caplacizumab In Patients With Acquired Thrombotic Thrombocytopenic Purpura
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-005229
NCT ID: NCT02553317
Sponsor Protocol Number: ALX0681-C301
About this study
The purpose of this study is to evaluate the effectiveness and safety of caplacizumab treatment in more rapidly curtailing ongoing microvascular thrombosis when administered in addition to standard of care treatment in subjects with an acute episode of acquired thrombotic thrombocytopenic purpura.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Adult male or female ≥ 18 years of age at the time of signing the informed consent form
- Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes)
- Requires initiation of daily PE treatment and has received PE treatment prior to randomization
- Other criteria as defined in the protocol
Exclusion Criteria
- Platelet count ≥100×10E9/L
- Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L
- Known other causes of thrombocytopenia
- Congenital TTP (known at the time of study entry)
- Pregnancy or breast-feeding
- Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
- Other criteria as defined in the protocol
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ronald Go, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available