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



Status:Completed
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:5/17/2018
Start Date:November 2015
End Date:August 2017

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A Phase III Double-blind, Randomized, Parallel Group, Multicenter Placebo-controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

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


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 TTP (initial or recurrent), which includes
thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g.,
schistocytes).

3. Requires initiation of daily PE treatment and has 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

6. Others as defined in the protocol
We found this trial at
20
sites
2202
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Durham, NC
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1919
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Atlanta, GA
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1784
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Birmingham, AL
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2578
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from 91732
Boston, MA
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7198
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from 91732
Brisbane,
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2194
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from 91732
Chapel Hill, NC
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Charleston, South Carolina 29412
2184
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from 91732
Charleston, SC
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2032
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from 91732
Cleveland, OH
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1959
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from 91732
Columbus, OH
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Greenville, South Carolina 29605
2019
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Greenville, SC
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1357
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from 91732
Houston, TX
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13
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from 91732
Los Angeles, CA
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1164
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Oklahoma City, OK
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2119
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from 91732
Pittsburgh, PA
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2245
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Rochester, NY
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2245
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from 91732
Rochester, NY
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1573
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from 91732
Saint Louis, MO
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570
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from 91732
Salt Lake City, UT
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2443
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from 91732
Valhalla, NY
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2126
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from 91732
Winston-Salem, NC
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