Who is sponsoring NCT02119715?

NCT02119715 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What condition does NCT02119715 study?

NCT02119715 studies Breast Cancer, Neutropenia, Febrile Neutropenia.

What drugs are being tested in NCT02119715?

Interventions: Pegylated rhG-CSF 100μg/kg, Pegylated rhG-CSF:150 μg/kg, rhG-CSF 5 μg/kg/day.

What is the status of NCT02119715?

NCT02119715 is currently COMPLETED.

Last reviewed 2014-04-17 · How we verify

A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy

NCT02119715 Phase 2 COMPLETED

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

Details

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 2
Status	COMPLETED
Enrolment	182
Start date	2011-02
Completion	2012-12

Conditions

Breast Cancer
Neutropenia
Febrile Neutropenia

Interventions

Pegylated rhG-CSF 100μg/kg
Pegylated rhG-CSF:150 μg/kg
rhG-CSF 5 μg/kg/day

Primary outcomes

Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L — 6 weeks
Proportion and the duration of subjects developing ANC lower than 1.0×109/L

Countries

China