Safety and Efficacy Studies of rHSA/GCSF Fusion Protein F... | NCT01919710

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

NCT01919710

Sponsor

Tianjin SinoBiotech Ltd.

Status

Completed

Last Update Posted

Jun 3, 2015Estimated

Enrollment

29Actual

Phase

Phase 1

Conditions

Underdose (Unintentional)
Cancer
Tumor

Interventions

rHSA/GCSF

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011L01837	Registry Identifier	China SFDA#2011L01837

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Nov 26, 2012

First Submission Date that Met QC Criteria

Aug 6, 2013

First Posted Date

Aug 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
Peking University Cancer Hospital & Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rHSA/GCSF for injection	Experimental	rHSA/GCSF Start from 300mcg	Drug: rHSA/GCSF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rHSA/GCSF	Drug	for treatment of neutropenia	rHSA/GCSF for injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
AUC	AUC after single and multiple dose of rHSA/GCSF	14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- chemotherapy induced neutropenia

Exclusion Criteria:

- treated with other biological drugs or other neutropenia therapy drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun ZHU, MD	Peking University Cancer Hospital & Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital		Beijing		100142	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D009503	Neutropenia

Ancestor Terms

ID	Term
D000380	Agranulocytosis
D007970	Leukopenia
D000095542	Cytopenia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided