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NCT01919710 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01919710
Other study ID # 9314-rHSA/GCSF
Secondary ID 2011L01837
Status Completed
Phase Phase 1
First received November 26, 2012
Last updated June 2, 2015
Start date October 2012
Est. completion date August 2014

Study information
Verified date June 2015
Source Tianjin SinoBiotech Ltd.
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date August 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- chemotherapy induced neutropenia

Exclusion Criteria:

- treated with other biological drugs or other neutropenia therapy drugs

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rHSA/GCSF
for treatment of neutropenia

Locations
Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (2)
Lead Sponsor Collaborator
Tianjin SinoBiotech Ltd. Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 14 days Yes
Secondary AUC AUC after single and multiple dose of rHSA/GCSF 14 days No
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