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

NCT02465801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2017-07-18

No results posted yet for this study

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.

Conditions

  • Chemotherapy-induced Neutropenia

Interventions

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

Sponsors & Collaborators

  • Tianjin SinoBiotech Ltd.

    lead INDUSTRY

Principal Investigators

  • Binhe Xu, MD · CAMS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-16
Primary Completion
2015-12-23
Completion
2016-04-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465801 on ClinicalTrials.gov