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Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

NCT02553317

CompletedPhase 3

Sponsor: Ablynx, a Sanofi company

Conditions: Acquired Thrombotic Thrombocytopenic Purpura

Interventions: Caplacizumab, Placebo

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany

The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
3. Required initiation of daily PE treatment and had received 1 PE treatment prior to randomization
4. Others as defined in the protocol

Exclusion Criteria:

1. Platelet count ≥100×10E9/L.
2. Serum creatinine level \>200 µmol/L in case platelet count is \> 30×10E9/L
3. Known other causes of thrombocytopenia
4. Congenital TTP (known at the time of study entry).
5. Pregnancy or breast-feeding.
6. Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
7. Others as defined in the protocol
Locations (101)
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • Atlanta, Georgia, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Rochester, New York, United States
  • Rochester, New York, United States
  • Valhalla, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Pittsburgh, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Greenville, South Carolina, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Brisbane, Australia
  • Melbourne, Australia
  • Melbourne, Australia
  • Melbourne, Australia
  • Melbourne, Australia
  • Melbourne, Australia
  • Perth, Australia
  • Sydney, Australia
  • Sydney, Australia
  • Vienna, Austria
  • Antwerp, Belgium
  • + 71 more on CT.gov