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

PHASE3CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

August 31, 2017

Study Completion Date

August 31, 2017

Conditions
Acquired Thrombotic Thrombocytopenic Purpura
Interventions
BIOLOGICAL

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."

BIOLOGICAL

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."

Trial Locations (101)

10595

Investigator Site, Valhalla

14642

Investigator Site, Rochester

15213

Investigator Site, Pittsburgh

27157

Investigator Site, Winston-Salem

27599

Investigator Site, Chapel Hill

27710

Investigator Site, Durham

27834

Investigator Site, Greenville

29425

Investigator Site, Charleston

30322

Investigator Site, Atlanta

35249

Investigator Site, Birmingham

43210

Investigator Site, Columbus

44195

Investigator SIte, Cleveland

55905

Investigator Site, Rochester

63110

Investigator Site, St Louis

73104

Investigator Site, Oklahoma City

77030

Investigator Site, Houston

84112

Investigator Site, Salt Lake City

90033

Investigator Site, Los Angeles

02114

Investigator Site, Boston

Unknown

Investigator Site, Brisbane

Investigator Site 1, Melbourne

Investigator Site 2, Melbourne

Investigator Site 3, Melbourne

Investigator Site 4, Melbourne

Investigator Site 5, Melbourne

Investigator Site, Perth

Investigator Site 1, Sydney

Investigator Site 2, Sydney

Investigator Site, Vienna

Investigator Site, Antwerp

Investigator Site, Brussels

Investigator Site, Haine-Saint-Paul

Investigator Site, La Louvière

Investigator Site, Leuven

Invesigator Site, Montreal

Investigator Site, London

Investigator Site, Toronto

Investigator Site, Brno

Investigator Site, Hradec Králové

Investigator Site, Olomouc

Investigator Site, Ostrava-Poruba

Investigator Site, Caen

Investigator Site, Lille

Investigator Site, Marseille

Investigator Site, Nantes

Investigator Site 1, Paris

Investigator Site 2, Paris

Investigator Site 3, Paris

Investigator Site 4, Paris

Investigator site 5, Paris

Investigator Site, Rouen

Investigator Site, Salouël

Investigator site, Cologne

Investigator site 1, Dresden

Investigator site 2, Dresden

Investigator site, Erlangen

Investigator site, Göppingen

Investigator site, Kiel

Investigator site, Leipzig

Investigator site, Würzburg

Investigator Site 1, Budapest

Investigator Site 2, Budapest

Investigator Site, Debrecen

Investigator Site 1, Be’er Ya‘aqov

Investigator Site 2, Be’er Ya‘aqov

Investigator Site, Haifa

Investigator Site 1, Jerusalem

Investigator Site 2, Jerusalem

Investigator Site, Nahariya

Investigator Site, Petah Tikva

Investigator Site, Tel Aviv

Investigator Site, Catania

Investigator Site 1, Milan

Investigator Site 2, Milan

Investigator Site, Pesaro

Investigator Site, Rome

Investigator Site, Vicenza

Investigator Site, Amersfoort

Investigator Site, Leiden

Investigator Site, Rotterdam

Investigator Site, Veldhoven

Investigator Site 1, Barcelona

Investigator Site 2, Barcelona

Investigator Site, Madrid

Investigator Site, Seville

Investigator Site 1, Valencia

Investigator Site 2, Valencia

Investigator site 3, Valencia

Investigator Site, Bern

Investigator Site, Zurich

Investigator Site, Ankara

Investigator Site 1, Denizli

Investigator Site 2, Denizli

Investigator site 3, Denizli

Investigator Site, Istanbul

Investigator Site, Kayseri

Investigator Site, Trabzon

Investigator Site, Bristol

Investigator Site, Liverpool

Investigator Site 1, London

Investigator Site 2, London

All Listed Sponsors
lead

Ablynx, a Sanofi company

INDUSTRY

NCT02553317 - Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura | Biotech Hunter | Biotech Hunter