Last updated on September 2018

Patient Preference for Pegfilgrastim (Neulasta ) Application Forms


Brief description of study

The study aims to compare two application forms (pre-filled syringe and On-body injector) of the same active drug (pegfilgrastim) in adult patients under chemotherapy regarding patient preference and health economics. Chemotherapy will be supported with pegfilgrastim for four subsequent chemotherapy cycles using alternating application forms.

Detailed Study Description

Neutropenia is one of the most common side effects of myelosuppressive chemotherapy. Febrile neutropenia and infectious complications are associated with chemotherapy dose delays and reductions and an increased risk of hospitalization. Prophylaxis with recombinant G-CSFs reduces the incidence, severity and duration of CIN and the risk of developing FN. Pegfilgrastim is available for over 10 years and is specified in the SmPC to be applied at least 24 hours after cytotoxic chemotherapy. For this application patients often have to return to their physician one day after chemotherapy treatment for the sole purpose of receiving pegfilgrastim subcutaneous (s.c.) injection. For different reasons, some of the patients requiring pegfilgrastim may not be able to return at this day and thus may not receive pegfilgrastim in accordance with the SmPC. The On-body injector for pegfilgrastim provides an option for patients not to return to the clinic/medical office the day after chemotherapy for their pegfilgrastim injection. The kit includes a single-use prefilled syringe co-packed with the On-body injector for pegfilgrastim. The On-body injector is applied to the patient's skin at the day of chemotherapy treatment and it automatically delivers pegfilgrastim approximately 27 h after the On-body injector was applied to the patient`s skin.

Patient-reported outcomes on preference for either application form can help to guide physicians' treatment choice, particularly in terms of application of the same active substance, in this study pegfilgrastim.

This study aims to compare the two application forms of pegfilgrastim (pegfilgrastim pre-filled syringe vs. On-body injector for pegfilgrastim) with regard to patient preference and health economy. A trial design with randomization of patients to receive the two application forms of pegfilgrastim in an alternating sequence for 4 cycles starting with either On-body injector for pegfilgrastim (Arm A) or pegfilgrastim pre-filled syringe (Arm B) was chosen. In this way, all patients will receive both application forms in order to be able to decide for their individual preference. Four cycles (that means each patient will receive each application form of pegfilgrastim twice) should be a sufficient number for the patient to make a decision. This design with two treatment arms serves to exclude a systematic bias that might be generated when starting with the same application form for all patients.

Clinical Study Identifier: NCT03619993

Contact Investigators or Research Sites near you

Start Over

Sina Grebhardt, PhD

Research Site
Aschaffenburg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Augsburg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Berlin, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Bonn, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Celle, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Dresden, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Erfurt, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Flensburg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Frankfurt an der Oder, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Freiburg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Goslar, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Halberstadt, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Heidelberg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Herne, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Hildesheim, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Kaiserslautern, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Kassel, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Mannheim, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Mayen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Naunhof, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Neunkirchen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Neustadt In Sachsen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Nordhorn, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Offenbach am Main, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Oldenburg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Ostfildern, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Passau, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Pirna, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Ratingen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Rostock, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Singen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Spremberg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Stolberg, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Stralsund, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Georgsmarienhütte, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Göttingen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Köthen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Mühlhausen, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Mülheim an der Ruhr, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
München, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Sömmerda, Germany
  Connect »

Sina Grebhardt, PhD

Research Site
Würselen, Germany
  Connect »