NCT02465801

Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Tianjin SinoBiotech Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients. Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.

Detailed description

* Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments. * Positive control：recombinant human granulocyte colony-stimulating factor injection. * Targeted patients: breast cancer * Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment. * Number of patients: 216 * Concomitant medicines will be conducted.

Conditions

• Chemotherapy-induced Neutropenia

Interventions

Type	Name	Description
DRUG	HSA-GCSF 1.2 mg	Human Serum Albumin GCSF 1.2mg at day 3 and Day 7
DRUG	HSA-GCSF 1.5 mg	Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7
DRUG	GCSF	GCSF 5 mcg/kg/day

Timeline

• Start date: 2014-12-16
• Primary completion: 2015-12-23
• Completion: 2016-04-26
• First posted: 2015-06-08
• Last updated: 2017-07-18

Locations

1 site across 1 country: China