Trials Sponsors Conditions Drugs Pricing

Conditions

Primary/Secondary Prevention High Risk for Febrile Neutropenia of Chemotherapy Regimens Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in Febrile Neutropenia

Keywords

Efbemalenograstim alfaprimary/secondary preventionfebrile neutropenia of chemotherapy regimens

Outcome Measures

Primary Outcomes (2)

Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 1st cycle of chemotherapy
Evaluate the incidence of grade ≥3 ANC at the end of Cycle 1 (Cycle 1 is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 2nd cycle of chemotherapy
Evaluate the incidence of grade ≥3 ANC at the end of Cycle 2 (Cycle 2 is 21 days)

Secondary Outcomes (7)

Incidence of febrile neutropenia (FN) of each cycle of chemotherapy
At the end of each cycle(each cycle is 21 days), an average of 3 months

Study Arms (1)

treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy

EXPERIMENTAL

Drug: Efbemalenograstim alfa Injection

Interventions

Efbemalenograstim alfa InjectionDrug

The patients with solid tumor who were at high risk for febrile neutropenia or intermediate risk of chemotherapy regimens associated with other risk factors in febrile neutropenia would be injected Efbemalenograstim alfa for primary/secondary prevention.

treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Willing to sign the informed consent form and be able to comply with the requirements of the protocol;
Age≥ 18 years old, ≤ 75 years old;

Sponsors & Collaborators

West China Hospital
Othercollaborator
Henan Cancer Hospital
Governmentlead

Study Sites (1)

The Henan cancer hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Zhenzhen LiuCONTACT0371-65588251 liuzhenzhen73@126.com

Central Study Contacts

Zhenzhen Liu, Dr.

CONTACT

0371-65588251 liuzhenzhen73@126.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director

Study Record Dates

First Submitted

April 22, 2025

First Posted

September 23, 2025

Study Start

January 1, 2025

Actual (reported)

Primary Completion

October 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Efbemalenograstim Alfa for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations