CompletedPhase 3

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

United States145 participantsStarted 2015-11

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

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
✕. Others as defined in the protocol

What they're measuring

Time to Platelet Count Response

Timeframe: Only data from the DB daily PE period (median = 5 days) up to the cut-off were used. The cut-off point was defined by whichever occured first: 1) 45 days of daily PE after start of study drug, 2) stop of daily PE, 3) stop of study drug (median = 34 days)

Trial details

NCT IDNCT02553317

SponsorAblynx, a Sanofi company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08

Results submitted2019-02-25

View on ClinicalTrials.gov More Acquired Thrombotic Thrombocytopenic Purpura trials