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

Phase 1CompletedNCT01919710

Tianjin SinoBiotech Ltd.29 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Underdose (Unintentional)Cancer Tumor

Interventions

rHSA/GCSFDRUG

for treatment of neutropenia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- chemotherapy induced neutropenia Exclusion Criteria: \- treated with other biological drugs or other neutropenia therapy drugs

Locations (1)

Beijing Cancer Hospital

Beijing, China

Outcomes

Primary Outcomes

Number of adverse events

Number of participants with adverse events as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF

Time frame: 14 days

Secondary Outcomes

AUC

AUC after single and multiple dose of rHSA/GCSF

Time frame: 14 days

Data from ClinicalTrials.gov

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