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Completed

NCT Number: NCT01919710

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

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

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Key information

Conditions

Underdose (Unintentional) Agranulocytosis Cancer Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neutropenia Tumor

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital

Beijing, 100142, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chemotherapy induced neutropenia

Exclusion criteria

  • treated with other biological drugs or other neutropenia therapy drugs

Treatment and study plan

rHSA/GCSF

Drug

for treatment of neutropenia

Other names: Long acting rhG-CSF fusion protein

Primary outcomes

  1. 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

Secondary outcomes

  1. AUC

    Time frame: 14 days

    AUC after single and multiple dose of rHSA/GCSF

Sponsors and collaborators

Lead sponsor

Tianjin SinoBiotech Ltd.

Industry

Collaborators

  • Peking University Cancer Hospital & Institute

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 9, 2013
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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