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Underdose (Unintentional) | Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia

Underdose (Unintentional) research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Underdose (Unintentional)

Cancer

Tumor

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:rHSA/GCSFfor treatment of neutropenia

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

rHSA/GCSF for injectionrHSA/GCSF Start from 300mcg

Study Status

Completed

Start Date: October 2012

Completed Date: August 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Number of adverse events

Secondary Outcome: AUC

Study sponsors, principal investigator, and references

Principal Investigator: Jun ZHU, MD

Lead Sponsor: Tianjin SinoBiotech Ltd.

Collaborator: Beijing Cancer Hospital

More information:https://clinicaltrials.gov/show/NCT01919710

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