A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

October 21, 2019

Primary Completion Date

May 19, 2021

Study Completion Date

May 19, 2021

Conditions
Thrombotic Thrombocytopenic Purpura
Interventions
DRUG

Caplacizumab (ALX-0081)

Pharmaceutical form:Lyophilized powder for solution for injection Route of administration: IV (first dose), SC (all subsequent doses)

DRUG

Plasma exchange (PE)

Pharmaceutical form:Plasma (e.g. fresh frozen plasma) Route of administration: Plasma exchange

DRUG

Corticosteroid treatment (Methylprednisolone or prednisolone)

Pharmaceutical form:Solution for injection or Tablet Route of administration: IV or Oral

DRUG

Immunosuppressive treatment (eg, rituximab)

Pharmaceutical form:Solution for injection (depending on product) Route of administration: IV (depending on product)

Trial Locations (12)

Unknown

Investigational Site Number 3920009, Iruma-Gun

Investigational Site Number 3920014, Kanazawa

Investigational Site Number 3920007, Kashihara-shi

Investigational Site Number 3920013, Kawasaki-Shi

Investigational Site Number 3920001, Kitakyushu-Shi

Investigational Site Number 3920002, Kumamoto

Investigational Site Number 3920003, Kurashiki-Shi

Investigational Site Number 3920010, Kyoto

Investigational Site Number 3920005, Maebashi

Investigational Site Number 3920015, Nagoya

Investigational Site Number 3920011, Osaka

Investigational Site Number 3920006, Sendai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY