NCT05531279

Brief Summary

This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 5, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

September 2, 2022

Last Update Submit

September 22, 2022

Conditions

Severe Aplastic Anemia

Keywords

G-CSF

Outcome Measures

Primary Outcomes (1)

  • total number of effective (ANC>0.5×109/L) days

    total number of effective (ANC\>0.5×109/L) days during 2 weeks of treatment(cases×days).

    2 weeks

Study Arms (3)

PEG-rhG-CSF group A

EXPERIMENTAL

PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.

Drug: PEG-rhG-CSF

PEG-rhG-CSF group B

EXPERIMENTAL

PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.

Drug: PEG-rhG-CSF

rhG-CSF group(short-acting )

EXPERIMENTAL

rhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.After monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSFDRUG

PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected; PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected; RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.

Also known as: rhG-CSF
PEG-rhG-CSF group APEG-rhG-CSF group BrhG-CSF group(short-acting )

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years old, male or female, or weight≥50kg.
  • Patients with severe or very severe aplastic anemia of absolute neutrophil value\< 0.5×109/L
  • ECOG score ≤ 2 points.
  • Normal renal function.

You may not qualify if:

  • Patients with clonal chromosomal abnormalities.
  • Patients with previous malignant tumors.
  • Patients with severe or uncontrolled infectious diseases and /or bleeding.
  • Patients with AIDS or syphilis positive.
  • Severe organ dysfunction.
  • Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission.
  • Allergic to G-CSF or PEG-rhG-CSF related components.
  • Participated in other clinical trials within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Related Publications (1)

  • Tichelli A, Schrezenmeier H, Socie G, Marsh J, Bacigalupo A, Duhrsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Hochsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13.

    PMID: 21233311RESULT

MeSH Terms

Conditions

Anemia, Aplastic

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

Study Officials

  • Liping Jing, Doctor

    Chinese Academy of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Fengkui Zhang, Doctor

CONTACT

+862223909229fkzhang@ihcams.ac.cn

Huihui Fan, Doctor

CONTACT

+862223909223fanhuihui@ihcams.ac.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

June 5, 2022

Primary Completion

June 5, 2025

Study Completion

January 5, 2026

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

We can share the plan after completing the experiment

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Follow-up and publication of the paper are planned for December 2025
Access Criteria
After the paper is written and published

Locations

CN(1)