The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Unnamed facility
Brno, Czechia
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Olomouc, Czechia
Unnamed facility
Prague, Czechia
Subjects Who Qualify As Treatment Responders
Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.
Time frame: Baseline thru Day 15 post treatment
Time to achieve a platelet count > 50 x 109/L
Time frame: Screening visit
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 1 (initiation of treatment)
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 2
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 5
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 8
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 11
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 22
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 15
Time to achieve a platelet count > 50 x 109/L
Time frame: Day 29 (study termination visit)
Duration of platelet response
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Giessen, Germany
Unnamed facility
Halle, Germany
Unnamed facility
Debrecen, Hungary
Unnamed facility
Győr, Hungary
Unnamed facility
Szeged, Hungary
Unnamed facility
Szombathely, Hungary
...and 1 more locations
Time frame: Screening visit
Duration of platelet response
Time frame: Day 1 (initiation visit)
Duration of platelet response
Time frame: Day 2
Duration of platelet response
Time frame: Day 5
Duration of platelet response
Time frame: Day 8
Duration of platelet response
Time frame: Day 11
Duration of platelet response
Time frame: Day 15
Duration of platelet response
Time frame: Day 22
Duration of platelet response
Time frame: Day 29 (study termination visit)
Maximum Platelet Count
Time frame: Screening visit
Maximum Platelet Count
Time frame: Day 1 (initiation visit)
Maximum Platelet Count
Time frame: Day 2
Maximum Platelet Count
Time frame: Day 5
Maximum Platelet Count
Time frame: Day 8
Maximum Platelet Count
Time frame: Day 11
Maximum Platelet Count
Time frame: Day 15
Maximum Platelet Count
Time frame: Day 22
Maximum Platelet Count
Time frame: Day 29 (study termination visit)
Number of Adverse Experiences
Time frame: Throughout the study period of approximately 11 months