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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Tianjin SinoBiotech Ltd.

Current Primary Outcome: Number of adverse events [ Time Frame: 14 days ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: AUC [ Time Frame: 14 days ]

AUC after single and multiple dose of rHSA/GCSF


Original Secondary Outcome: Same as current

Information By: Tianjin SinoBiotech Ltd.

Dates:
Date Received: November 26, 2012
Date Started: October 2012
Date Completion:
Last Updated: June 2, 2015
Last Verified: June 2015