Back to resultsSafety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia
Primary Purpose
Underdose (Unintentional), Cancer, Tumor
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
rHSA/GCSF
Sponsored by
About this trial
This is an interventional treatment trial for Underdose (Unintentional) focused on measuring Neutropenia, chemotherapy, rHSA/GCSF
Eligibility Criteria
Inclusion Criteria:
- chemotherapy induced neutropenia
Exclusion Criteria:
- treated with other biological drugs or other neutropenia therapy drugs
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rHSA/GCSF for injection
Arm Description
rHSA/GCSF Start from 300mcg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
AUC
AUC after single and multiple dose of rHSA/GCSF
Full Information
NCT ID
NCT01919710
First Posted
November 26, 2012
Last Updated
June 2, 2015
Sponsor
Tianjin SinoBiotech Ltd.
Collaborators
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT01919710
Brief Title
Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia
Official Title
Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin SinoBiotech Ltd.
Collaborators
Peking University Cancer Hospital & Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underdose (Unintentional), Cancer, Tumor
Keywords
Neutropenia, chemotherapy, rHSA/GCSF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rHSA/GCSF for injection
Arm Type
Experimental
Arm Description
rHSA/GCSF Start from 300mcg
Intervention Type
Drug
Intervention Name(s)
rHSA/GCSF
Other Intervention Name(s)
Long acting rhG-CSF fusion protein
Intervention Description
for treatment of neutropenia
Primary Outcome Measure Information:
Title
Number of adverse events
Description
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 Outcome Measure Information:
Title
AUC
Description
AUC after single and multiple dose of rHSA/GCSF
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- chemotherapy induced neutropenia
Exclusion Criteria:
- treated with other biological drugs or other neutropenia therapy drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun ZHU, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia
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