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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05910164




Registration number
NCT05910164
Ethics application status
Date submitted
9/06/2023
Date registered
18/06/2023
Date last updated
1/10/2024

Titles & IDs
Public title
Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim
Scientific title
Single-center, Randomized, Crossover Clinical Study to Assess Patient Preference Between the Use of a Prefilled Syringe or a Prefilled Pen Device for Pegfilgrastim Administration (PELGRAZ) as Primary Prophylaxis of Chemotherapy-related Neutropenia
Secondary ID [1] 0 0
ID RCB: 2022-A01465-38
Secondary ID [2] 0 0
IR-2022/0011
Universal Trial Number (UTN)
Trial acronym
PELGRAZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient Preference 0 0
Febrile Neutropenia, Drug-Induced 0 0
Patient Satisfaction 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - PELGRAZ prefilled syringe or PELGRAZ prefilled pen

A) administration starting with prefilled syringe - - Group A = Phase 1 then phases 2, 3, 4

The study protocol consists of 4 different stages

* Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE)
* Phase 2: pen injection guided (thanks to the detailed information) by the IDE
* Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase
* Phase 4: injection by pen in complete autonomy, patient alone

B) administration starting with prefilled pen - - Group B = Phase 2, 3, 4 then phase 1

The study protocol consists of 4 different stages

* Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE)
* Phase 2: pen injection guided (thanks to the detailed information) by the IDE
* Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase
* Phase 4: injection by pen in complete autonomy, patient alone


Treatment: Devices: PELGRAZ prefilled syringe or PELGRAZ prefilled pen
PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
questionnaire
Timepoint [1] 0 0
120 days
Secondary outcome [1] 0 0
questionnaire, specific questions
Timepoint [1] 0 0
120 days

Eligibility
Key inclusion criteria
* 18 years old and older
* Patients with solid tumors, Hodgkin's lymphoma, non-Hodgkin's lymphoma and receiving myelosuppressive chemotherapy with a risk of NF of 10-20% (individual risk factors), or = 20% (primary prevention of neutropenia) and receiving PELGRAZ ® in accordance with CPR
* Prediction of the risk of NF without filgrastim or pegfilgrastim determined according to the recommendations of the EORTC
* ECOG = 2
* Free and informed consent obtained
* Patient affiliated to a social security system or beneficiary of such a scheme
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy
* Breastfeeding
* Patients receiving concurrent radiotherapy
* Second cancer treated with chemotherapy
* Participation in any other clinical trial within 30 days prior to recruitment
* Concomitant myelosuppressive therapy, e.g. ex. immunosuppressive therapy
* History of severe hypersensitivity reaction to drugs intended for use and/or drugs derived from E. coli

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/10/2024
Actual
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Ile-de-France

Funding & Sponsors
Primary sponsor type
Other
Name
Institut Rafael
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alain TOLEDANO, MD
Address 0 0
Institut Rafael
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05910164