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

Tianjin SinoBiotech

Status and phase: Completed; Phase 1

Conditions: Tumor; Cancer; Underdose (Unintentional)

Treatments: Drug: rHSA/GCSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01919710

9314-rHSA/GCSF

2011L01837 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chemotherapy induced neutropenia

Exclusion criteria

• treated with other biological drugs or other neutropenia therapy drugs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

rHSA/GCSF for injection

Experimental group

Description:

rHSA/GCSF Start from 300mcg

Treatment:

Drug: rHSA/GCSF