NCT03251768

Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Tianjin SinoBiotech Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia

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. * Targeted patients: breast cancer * Subjects were randomly divided into two groups. The test group received recombinant human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg treatment. Positive control group received recombinant human granulocyte colony stimuli Factor injection therapy * Number of patients: 80

Conditions

• Chemotherapy-induced Neutropenia

Interventions

Type	Name	Description
DRUG	rHSA-GCSF 2.4mg	Human Serum Albumin GCSF 2.4mg at day 3 and day 7
DRUG	GCSF	GCSF 5 mcg/kg/day

Timeline

• Start date: 2017-10-19
• Primary completion: 2018-07-23
• Completion: 2019-04-24
• First posted: 2017-08-16
• Last updated: 2019-09-13

Locations

1 site across 1 country: China