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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00000313 |
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Date of registration:
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18/01/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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HEXAFIL: Non-interventional study for supportive treatment of chemotherapy induced neutopenia with Filgrastim HEXAL®
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Scientific title:
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HEXAFIL: Non-interventional study for supportive treatment of chemotherapy induced neutopenia with Filgrastim HEXAL® - HEXAFIL |
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Date of first enrolment:
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29/01/2010 |
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Target sample size:
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1460 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00000313 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Hans
Tesch |
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Address:
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Im Prüfling 17 -19
60389
Frankfurt
Germany |
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Telephone:
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069-451080 |
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Email:
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Affiliation:
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Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus |
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Name:
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Hans
Tesch |
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Address:
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Im Prüfling 17 -19
60389
Frankfurt
Germany |
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Telephone:
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069-451080 |
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Email:
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Affiliation:
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Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.) Patients undergoing antineoplastic therapy and who are treated either prophylactically or interventionally with Filgrastim HEXAL® in case of emerging neutropenia.
2.) Male and female patients at least 18 years old (no upper age limit)
3.) Signed informed consent of the patient to the collection and forwarding of pseudonymised data
Exclusion criteria: 1.) Contraindication according Summary of Products Characteristics (SPC) Filgrastim HEXAL®
2.) Furthermore, patients should not be included in the non-interventional study if they fulfill at least one of the following criteria:
a.) Patients who have not signed the informed consent form
b.) Patients who have been treated with G-CSF in the current line of chemotherapy treatment
c) Female patients who are pregnant or breast-feeding
d.) Patients undergoing myelosuppressive or myeloablative therapy followed by autologous transplantation of PBBC, and
e.) Patients who are diagnosed with myelodysplastic syndrome (MDS)
f.) Patients who are diagnosed with chronic myelogenous leukemia (CML)
g.) Patients who are diagnosed with secondary AML
h.) Patients who are scheduled for myeloablative treatment followed by bone marrow transplantation
i). Patients who are diagnosed with severe chronic neutropenia (SCN), congenital neutropenia, or idiopathic or cyclic neutropenia
j.) Patients aged < 55 year who are diagnosed with de novo AML with good cytogenetics [t(8;21), t(15;17), and inv(16)]
k.) Patients who are diagnosed with HIV
l.) Patients who are diagnosed with hereditary fructose intolerance
In line with the Amendment No. 1 (approved by CEC on 06/28/2011), active since 08/17/2011:
m). Patients who have been treated with filgrastim HEXAL® for the treatment of chemotherapy-induced neutropenia and who already participated in the non-interventional study HEXAFIL
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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chemotherapy induced neutropenia
D70.1
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D70.1
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Primary Outcome(s)
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Safety profile of Filgrastim HEXAL®
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Secondary Outcome(s)
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Efficacy of Filgrastim HEXAL® treatment - application period of Filgrastim HEXAL® (measured as number of days applied per chemotherapy cycle); occurrence of febrile neutropenia, leukocyte count observed before the start of chemotherapy cycle (if available) and lowest leukocyte count observed during the chemotherapy cycle (if available); correlation of Filgrastim HEXAL® administration to tumor entitiy and previous therapy regimen; supportive treatment with antibiotics / fungicides ; assessment of self-administration of Filgrastim HEXAL® (s.c.) by the patients, assessment of the needle protection system; overall rating for efficacy and tolerability by the responsible physician.
Additional secundary parameters in line with the Amendment No. 1, active since 08/17/2011:
Analysis of the ANC (absolute neutrophil count) before and lowest ANC during the observed chemotherapy cycle; intention of supportive antibiotics/antimycotics therapy
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Secondary ID(s)
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U1111-1113-2795
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Source(s) of Monetary Support
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HEXAL AG Deutschland
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Ethics review
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Status: Approved
Approval date: 13/01/2010
Contact:
ethikkommission@laekh.de
Ethik-Kommission der Landesärztekammer Hessen
+49-69-97672209
ethikkommission@laekh.de
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