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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01574235
Other study ID # NEXT
Secondary ID
Status Completed
Phase N/A
First received April 4, 2012
Last updated July 27, 2015
Start date October 2011
Est. completion date February 2014

Study information

Verified date July 2015
Source Hospira, Inc.
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.


Recruitment information / eligibility

Status Completed
Enrollment 2114
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18 years

- Patients presenting with a solid tumor or a malignant hemopathy,

- Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle),

- Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias

Exclusion Criteria:

- Patients presenting with a chronic myeloproliferative syndrome,

- Patients presenting with a myelodysplastic syndrome,

- Patients showing hypersensitivity to any of the ingredients of Nivestim®,

- Patients not receiving chemotherapy,

- Patients who were already included in the study during a previous chemotherapy line

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Biological:
Nivestim®


Locations

Country Name City State
France Ch Du Pays D'Aix Aix En Provence Marseille
France Clinique Rambot Aix En Provence Marseille
France MEDIPOLE Aix Les Bains Rhone Alpes
France CHG Ales Languedoc
France Ico Angers Angers Pays de La Loire
France CHRA Annecy Rhone Alpes
France Victor Dubos Argenteuil Paris Nord
France Clinique des Bonnettes Arras Nord
France Ch Duffaut Avignon Marseille
France CHG Beziers Languedoc
France CH Boulogne-sur-Mer Boulogne Nord
France Clinique Porte St Cloud Boulogne Paris Ouest
France Clinique CONVERT Bourg en bresse Rhone Alpes
France Chr Brive Brive Massif Central
France CHG Cahors Cahors Midi Pyrennees
France CHG Carcassonne Languedoc
France Polyclinique Cesson Cesson Basse Normandie
France CHG William MOREY Chalon S/s Bourgogne
France Ch Chambery Chambery Rhone Alpes
France Ch Cholet Cholet Pays de La Loire
France Chu Estaing Clermont Massif Central
France Chu Gabriel Montpied Clermont Massif Central
France Pole Sante Republique Clermont Massif Central
France BEAUJON Clichy Paris Ouest
France Hopital Louis Pasteur Colmar Alsace
France CHG Dieppe Dieppe Haute Normandie
France CHU du BOCAGE Dijon Bourgogne
France CH de Draguignan Draguignan Paca
France Hopital Jean Monnet Epinal Alsace
France Clinique Pasteur Evreux Haute Normandie
France CHI de Fréjus Frejus Paca
France Chi Frejus - St Raphael Frejus Paca
France CHICAS GAP Paca
France Chu Grenoble Grenoble Rhone Alpes
France Clinique Ste Marguerite Hyeres Paca
France Clinique du Cap d'Or La Seyne Sur Mer Paca
France Hopital Mignot Le Chesnay Paris Ouest
France Ch Le Mans Le Mans Pays de La Loire
France Victor Hugo Le Mans Pays de La Loire
France Hopital Franco Britannique Levallois Perret Paris Ouest
France Centre Oscar Lambret Lille Nord
France Hopital Des Courses Maisons Laffitte Paris Ouest
France Chp Clairval Marseille
France Chu Timone Marseille
France Fondation Saint Joseph Marseille
France Hopital A.Pare Marseille
France IPC Marseille
France Clinique St Faron Meaux Champagne
France CH Jacques Monod Montivilliers Haute Normandie
France Clinique Vitalia Desertines Montlucon Massif Central
France Chu St Eloi Montpellier Languedoc
France Clinique Beausoleil Montpellier Languedoc
France CH Emile Muller Mulhouse Alsace
France HARTMANN Neuilly/seine Paris Ouest
France Clinique Belvédère Nice Paca
France CHU Caremeau Nimes Languedoc
France Clinique Ste Marie Osny Paris Nord
France Saint Antoine Paris Paris Nord
France Saint Louis Paris Paris Nord
France TENON Paris Paris Nord
France Chg St Jean Perpignan Languedoc
France Hpt Rene Dubos Pontoise Paris Nord
France Cac Jean Godinot Reims Champagne
France Chu Rennes Rennes Basse Normandie
France CHU SUD Rennes Basse Normandie
France Clinique St Laurent Rennes Basse Normandie
France CHR Roanne Massif Central
France Centre frederic joliot curie Rouen Haute Normandie
France Centre Rene Huguenin St Cloud Paris Ouest
France Icl St Etienne St Etienne Massif Central
France CHG St Gaudens St Gaudens Midi Pyrennees
France Chp St Greg St Gregoire Basse Normandie
France Ch St Malo St Malo Basse Normandie
France Hopital St Quentin St Quentin Champagne
France CAC Paul Strauss Strasbourg Alsace
France Chu Hopital Civil Strasbourg Alsace
France STE ANNE Strasbourg Alsace
France Hopital Foch Suresnes Paris Ouest
France Clinique de l'Ormeau Tarbes Midi Pyrennees
France CH Sainte Musse Toulon Paca
France H.I.A Saint Anne Toulon Paca
France CHU Purpan Toulouse Midi Pyrennees
France Clinique Pasteur Toulouse Midi Pyrennees
France Inst. Claudius Regaud Toulouse Midi Pyrennees
France Hopital Troyes Troyes Champagne
France Ch Valence Valence Rhone Alpes
France Clinique des Dentellieres Valenciennes Nord

Sponsors (1)

Lead Sponsor Collaborator
Hospira, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy. The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection. Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months Yes
Secondary Efficacy of treatment with Nivestim® Assess the efficacy of the treatment with Nivestim® by studying occurrence of febrile neutropenia, infection and the impact of these events on the chemotherapy treatment (cycle postponement, dose reduction) Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months No
Secondary Characteristics of the patients treated with Nivestim® in real-life practice Describe the characteristics of the patients treated with Nivestim® in real-life practice, At Visit 1 No
Secondary Methods of treatment with Nivestim® Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice. Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months No
Secondary Profiles of the physicians participating in the study Describe the profiles of the physicians participating in the study At visit 1 No
Secondary General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF) Assess the general practice of these physicians with regard to prescription of G-CSF At visit 1 No
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