NCT01919710

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

November 26, 2012

Last Update Submit

June 2, 2015

Conditions

Underdose (Unintentional)CancerTumor

Keywords

NeutropeniachemotherapyrHSA/GCSF

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • AUC

    14 days

Study Arms (1)

rHSA/GCSF for injection

EXPERIMENTAL

rHSA/GCSF Start from 300mcg

Drug: rHSA/GCSF

Interventions

rHSA/GCSFDRUG

for treatment of neutropenia

Also known as: Long acting rhG-CSF fusion protein
rHSA/GCSF for injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- chemotherapy induced neutropenia

You may not qualify if:

  • \- treated with other biological drugs or other neutropenia therapy drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

Location

MeSH Terms

Conditions

NeoplasmsNeutropenia

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Jun ZHU, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

August 9, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

CN(1)