Filgrastim Hexal ( DrugBank: Filgrastim )


1 disease
IDDisease name (Link within this page)Number of trials
65Primary immunodeficiency2

65. Primary immunodeficiency


Clinical trials : 482 Drugs : 653 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-001118-32-SE
(EUCTR)
03/02/201206/12/2011Twelve-month study on the immunogenicity (i.e. the ability of the study medication to provoke an immune response), safety and efficacy of the study medication Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropeniaTwelve-month study on the immunogenicity, safety, and efficacy of Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropenia Severe chronic neutropenia (i.e. congenital neutropenia, cyclic neutropenia and chronic idiopathic neutropenia)
MedDRA version: 18.0;Level: PT;Classification code 10051645;Term: Idiopathic neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 18.0;Classification code 10053176;Term: Cyclic neutropenia;Level: LLT;Classification code 10069819;Term: Congenital neutropenia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Zarzio
INN or Proposed INN: FILGRASTIM
Trade Name: Zarzio
INN or Proposed INN: FILGRASTIM
Sandoz GmbHNULLNot RecruitingFemale: yes
Male: yes
40Phase 4Germany;Sweden
2EUCTR2011-001118-32-DE
(EUCTR)
25/05/201127/04/2011Twelve-month study on the immunogenicity (i.e. the ability of the study medication to provoke an immune response), safety and efficacy of the study medication Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropeniaTwelve-month study on the immunogenicity, safety, and efficacy of Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropenia Severe chronic neutropenia (i.e. congenital neutropenia, cyclic neutropenia and chronic idiopathic neutropenia)
MedDRA version: 14.1;Level: PT;Classification code 10051645;Term: Idiopathic neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10069819;Term: Congenital neutropenia;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10053176;Term: Cyclic neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Filgrastim Hexal
INN or Proposed INN: FILGRASTIM
Trade Name: Filgrastim Hexal
INN or Proposed INN: FILGRASTIM
Product Name: EP2006 (Filgrastim)
Product Code: EP2006
INN or Proposed INN: FILGRASTIM
Sandoz GmbHNULLNot RecruitingFemale: yes
Male: yes
40Germany;Sweden