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

Phase 1

Completed

• Conditions: Cancer; Underdose (Unintentional); Tumor
• Interventions: Drug: rHSA/GCSF

• Registration Number: NCT01919710
• Lead Sponsor: Tianjin SinoBiotech Ltd.

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-09
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• chemotherapy induced neutropenia

Exclusion Criteria

• treated with other biological drugs or other neutropenia therapy drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rHSA/GCSF for injection	rHSA/GCSF	rHSA/GCSF Start from 300mcg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AUC	14 days	AUC after single and multiple dose of rHSA/GCSF

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China