Who is sponsoring NCT01560195?

NCT01560195 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What condition does NCT01560195 study?

NCT01560195 studies NSCLC, Neutropenia, Febrile Neutropenia.

What drugs are being tested in NCT01560195?

Interventions: Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg, placebo and rhG-CSF 5ug/kg/d.

What is the status of NCT01560195?

NCT01560195 is currently UNKNOWN.

Last reviewed 2012-11-04 · How we verify

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy

NCT01560195 Phase 3 UNKNOWN

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 ﬁlgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.

Details

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	150
Start date	2012-04

Conditions

NSCLC
Neutropenia
Febrile Neutropenia

Interventions

Pegylated rhG-CSF: 100µg/kg
Pegylated rhG-CSF: 6mg
placebo and rhG-CSF 5ug/kg/d

Primary outcomes

Rate of grade 3/4 neutropenia in cycle 1 — 21 days
the rate of ANC lower than 1.0 × 109/L

Countries

China