The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
6 mg
6 mg
Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L
Grade 4 neutropenia measured in days
Time frame: 3 weeks
Incidence of febrile neutropenia (FN) (strict definition)
Body temperature of \>38.5°C for at least one hour and ANC\<1\*10\^9/L
Time frame: 18 weeks
Incidence of FN
A single temperature of ≥38.3°C or ≥38.0°C for at least one hour and ANC \<1 \* 10\^9/L
Time frame: 18 weeks
Incidence of very severe neutropenia
The occurrence of at least one incidence of ANC \<0.1 \* 10\*9/L
Time frame: 3 weeks
Incidence of infections
Incidence and severity of infections
Time frame: 18 weeks
Time to ANC recovery
The time in days from start of chemotherapy administration until the ANC increases to ≥1.0 x 109/L, ≥1.5 x 109/L, and ≥2.0 x 109/L after the expected nadir
Time frame: 3 weeks
Summary of participants with adverse events
Time frame: 9 Months
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Teva Investigational Site 32284
Aurich, Germany
Teva Investigational Site 32314
Bad Soden am Taunus, Germany
Teva Investigational Site 32267
Berlin, Germany
Teva Investigational Site 32277
Berlin, Germany
Teva Investigational Site 32292
Bochum, Germany
Teva Investigational Site 32400
Bonn, Germany
Teva Investigational Site 32318
Bonn, Germany
Teva Investigational Site 32294
Bottrop, Germany
Teva Investigational Site 32275
Cologne, Germany
Teva Investigational Site 32282
Dresden, Germany
...and 50 more locations