The Study on the Pharmacokinetics of PEG-rhG-CSF in Child... | NCT02953730

Studies
The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents

NCT02953730

Sponsor

Chinese Academy of Medical Sciences

Status

Completed

Last Update Posted

Nov 3, 2016Estimated

Enrollment

9Actual

Phase

Phase 4

Conditions

Acute Lymphoid Leukemia

Interventions

PEG-rhG-CSF

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

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

Sep 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Not provided

First Submitted Date

Nov 1, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 3, 2016Estimated

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

Nov 1, 2016

Last Update Posted Date

Nov 3, 2016Estimated

Description Module

Brief Summary

The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
PEG-rhG-CSF	Experimental		Drug: PEG-rhG-CSF

Name	Type	Description	Arm Group Labels	Other Names
PEG-rhG-CSF	Drug		PEG-rhG-CSF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peak concentration(Cmax)		1 year
elimination half life(t 1/2kel)		1 year
area under the curve(AUC)		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age≤18 years old, gender no limited.
Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
Previously not received radiotherapy.
Karnofsky Performance Scores ( KPS)≥60.
The expected survival time was >3 months.
Neutropenia or agranulocytosis, no bleeding tendency.
No significant cardiac dysfunction or metabolic disease.
TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） < 2.5×ULN（upper limit of normal）.
BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）<1.5×ULN.
Written informed consent are acquired.

Exclusion Criteria:

With a history of systemic radiotherapy.
Infection difficult to control, the body temperature ≥ 38℃.
Other situation that investigators consider as contra-indication for this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaofan Zhu, MD	Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences		Tianjin	Tianjin Municipality	300020	China

Type	Date	Date Unknown
Release	Feb 17, 2021
Reset	Mar 10, 2021
Release	Aug 11, 2021
Reset	Sep 7, 2021

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C423652	pegylated granulocyte colony-stimulating factor

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 17, 2021			Mar 10, 2021
Aug 11, 2021