Who is sponsoring NCT01611051?

NCT01611051 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What condition does NCT01611051 study?

NCT01611051 studies Breast Cancer, Neutropenia, Febrile Neutropenia.

What drugs are being tested in NCT01611051?

Interventions: Drug: Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg, rhG-CSF 5ug/kg/day.

What is the status of NCT01611051?

NCT01611051 is currently COMPLETED.

Last reviewed 2013-01-05 · How we verify

A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy

NCT01611051 Phase 3 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 and phase 2 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 3
Status	COMPLETED
Enrolment	330
Start date	2012-03

Conditions

Breast Cancer
Neutropenia
Febrile Neutropenia

Interventions

Drug: Pegylated rhG-CSF: 100µg/kg
Pegylated rhG-CSF: 6mg
rhG-CSF 5ug/kg/day

Primary outcomes

Rate and the duration of grade 3/4 neutropenia in cycle 1 — 21 days
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.

Countries

China