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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia<

Brief 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 Summary:

  • 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.

Sponsor: Tianjin SinoBiotech Ltd.

Current Primary Outcome: The mean of duration for class IV neutrophilic granulocytopenia [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The mean of duration for class IV neutrophilic granulocytopenia [ Time Frame: 8 weeks ]
  • The mean of duration for ANC up to 2.0×109/L [ Time Frame: 8 weeks ]
  • ANC [ Time Frame: 8 weeks ]
  • The usage of antibiotics [ Time Frame: 8 weeks ]
  • febrile neutropenia [ Time Frame: 8 weeks ]


Original Secondary Outcome: Same as current

Information By: Tianjin SinoBiotech Ltd.

Dates:
Date Received: November 17, 2014
Date Started: December 2014
Date Completion: April 2016
Last Updated: November 2, 2015
Last Verified: November 2015