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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acquired Thrombotic Thrombocytopenic Purpura

In brief

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

Key facts

Study ID

NCT02553317

Run by

Ablynx, a Sanofi company

People needed

145

Starts

2015-11-01

Expected to finish

2017-08-01

Last updated by the study team

2023-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
• 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).
• Required initiation of daily PE treatment and had received 1 PE treatment prior to randomization
• Others as defined in the protocol

You may not qualify if…

• 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
• Others as defined in the protocol

Where it is running

• Investigator Site — Los Angeles, California, United States
• Investigator Site — Atlanta, Georgia, United States
• Investigator Site — Boston, Massachusetts, United States
• Investigator Site — St Louis, Missouri, United States
• Investigator Site — Rochester, New York, United States
• Investigator Site — Rochester, New York, United States
• Investigator Site — Valhalla, New York, United States
• Investigator Site — Chapel Hill, North Carolina, United States
• Investigator Site — Durham, North Carolina, United States
• Investigator Site — Winston-Salem, North Carolina, United States
• Investigator SIte — Cleveland, Ohio, United States
• Investigator Site — Columbus, Ohio, United States
• Investigator Site — Oklahoma City, Oklahoma, United States
• Investigator Site — Pittsburgh, Pennsylvania, United States
• Investigator Site — Charleston, South Carolina, United States
• Investigator Site — Greenville, South Carolina, United States
• Investigator Site — Houston, Texas, United States
• Investigator Site — Salt Lake City, Utah, United States
• Investigator Site — Brisbane, Australia
• Investigator Site 1 — Melbourne, Australia
• Investigator Site 2 — Melbourne, Australia
• Investigator Site 3 — Melbourne, Australia
• Investigator Site 4 — Melbourne, Australia
• Investigator Site 5 — Melbourne, Australia
• Investigator Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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