Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
NCT ID: NCT02553317
Last Updated: 2023-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
145 participants
INTERVENTIONAL
2015-11-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Caplacizumab
Caplacizumab 10 mg once daily
Caplacizumab
* First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.
* Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.
* Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
Placebo
Placebo once daily
Placebo
* First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.
* Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.
* Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
Interventions
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Caplacizumab
* First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.
* Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.
* Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
Placebo
* First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.
* Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.
* Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Ablynx, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Ablynx NV
Locations
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Investigator Site
Birmingham, Alabama, United States
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
Perth, , Australia
Investigator Site 1
Sydney, , Australia
Investigator Site 2
Sydney, , Australia
Investigator Site
Vienna, , Austria
Investigator Site
Antwerp, , Belgium
Investigator Site
Brussels, , Belgium
Investigator Site
Haine-Saint-Paul, , Belgium
Investigator Site
La Louvière, , Belgium
Investigator Site
Leuven, , Belgium
Invesigator Site
Montreal, Quebec, Canada
Investigator Site
London, , Canada
Investigator Site
Toronto, , Canada
Investigator Site
Brno, , Czechia
Investigator Site
Hradec Králové, , Czechia
Investigator Site
Olomouc, , Czechia
Investigator Site
Ostrava-Poruba, , Czechia
Investigator Site
Caen, , France
Investigator Site
Lille, , France
Investigator Site
Marseille, , France
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Nantes, , France
Investigator Site 1
Paris, , France
Investigator Site 2
Paris, , France
Investigator Site 3
Paris, , France
Investigator Site 4
Paris, , France
Investigator site 5
Paris, , France
Investigator Site
Rouen, , France
Investigator Site
Salouël, , France
Investigator site
Cologne, , Germany
Investigator site 1
Dresden, , Germany
Investigator site 2
Dresden, , Germany
Investigator site
Erlangen, , Germany
Investigator site
Göppingen, , Germany
Investigator site
Kiel, , Germany
Investigator site
Leipzig, , Germany
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Würzburg, , Germany
Investigator Site 1
Budapest, , Hungary
Investigator Site 2
Budapest, , Hungary
Investigator Site
Debrecen, , Hungary
Investigator Site 1
Be’er Ya‘aqov, , Israel
Investigator Site 2
Be’er Ya‘aqov, , Israel
Investigator Site
Haifa, , Israel
Investigator Site 1
Jerusalem, , Israel
Investigator Site 2
Jerusalem, , Israel
Investigator Site
Nahariya, , Israel
Investigator Site
Petah Tikva, , Israel
Investigator Site
Tel Aviv, , Israel
Investigator Site
Catania, , Italy
Investigator Site 1
Milan, , Italy
Investigator Site 2
Milan, , Italy
Investigator Site
Pesaro, , Italy
Investigator Site
Rome, , Italy
Investigator Site
Vicenza, , Italy
Investigator Site
Amersfoort, , Netherlands
Investigator Site
Leiden, , Netherlands
Investigator Site
Rotterdam, , Netherlands
Investigator Site
Veldhoven, , Netherlands
Investigator Site 1
Barcelona, , Spain
Investigator Site 2
Barcelona, , Spain
Investigator Site
Madrid, , Spain
Investigator Site
Seville, , Spain
Investigator Site 1
Valencia, , Spain
Investigator Site 2
Valencia, , Spain
Investigator site 3
Valencia, , Spain
Investigator Site
Bern, , Switzerland
Investigator Site
Zurich, , Switzerland
Investigator Site
Ankara, , Turkey (Türkiye)
Investigator Site 1
Denizli, , Turkey (Türkiye)
Investigator Site 2
Denizli, , Turkey (Türkiye)
Investigator site 3
Denizli, , Turkey (Türkiye)
Investigator Site
Istanbul, , Turkey (Türkiye)
Investigator Site
Kayseri, , Turkey (Türkiye)
Investigator Site
Trabzon, , Turkey (Türkiye)
Investigator Site
Bristol, , United Kingdom
Investigator Site
Liverpool, , United Kingdom
Investigator Site 1
London, , United Kingdom
Investigator Site 2
London, , United Kingdom
Countries
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References
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Peyvandi F, Cataland S, Scully M, Coppo P, Knoebl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis. Blood Adv. 2021 Apr 27;5(8):2137-2141. doi: 10.1182/bloodadvances.2020001834.
Knoebl P, Cataland S, Peyvandi F, Coppo P, Scully M, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study. J Thromb Haemost. 2020 Feb;18(2):479-484. doi: 10.1111/jth.14679. Epub 2019 Dec 9.
Scully M, Cataland SR, Peyvandi F, Coppo P, Knobl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Callewaert F, Biswas D, De Winter H, Zeldin RK; HERCULES Investigators. Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2019 Jan 24;380(4):335-346. doi: 10.1056/NEJMoa1806311. Epub 2019 Jan 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001098-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALX0681-C301
Identifier Type: -
Identifier Source: org_study_id
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