Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia

Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01919710

Enrollment

Registered

2013-08-09

Start date

2012-10-31

Completion date

2014-08-31

Last updated

2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Tumor, Underdose (Unintentional)

Keywords

Neutropenia, chemotherapy, rHSA/GCSF

Brief summary

Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.

Detailed description

A dosage climbing for the safety and efficacy studies for the neutropenia induced by chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the neutropenia.

Interventions

DRUGrHSA/GCSF

for treatment of neutropenia

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

\- chemotherapy induced neutropenia

Exclusion criteria

\- treated with other biological drugs or other neutropenia therapy drugs

Design outcomes

Primary

Measure	Time frame	Description
Number of adverse events	14 days	Number of participants with adverse events as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF

Secondary

Measure	Time frame	Description
AUC	14 days	AUC after single and multiple dose of rHSA/GCSF

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026