OXERVATE ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
53シェーグレン症候群1

53. シェーグレン症候群


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003749-39-IT
(EUCTR)
15/12/202115/10/2021A 4 week, Phase III, multicenter, double-masked, study to evaluate safety and efficacy of Oxervate® (cenegermin) 20 mcg/mL ophthalmic solution in patients with severe Sjogren’s dry eye disease under treatment with Cyclosporine A.A 4 week, Phase III, multicenter, double-masked, vehicle-controlled study to evaluate safety and efficacy of Cenegermin (Oxervate®) 20 mcg/mL ophthalmic solution versus vehicle, in patients with severe Sjogren’s dry eye disease under treatment with Cyclosporine A. - NGF0221 Severe Sjogren’s dry eye disease
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Oxervate
Product Name: OXERVATE
Product Code: [Recombinant Human Nerve Growth Factor (rhNGF)]
INN or Proposed INN: Cenegermin
Other descriptive name: Recombinant form of human nerve growth factor produced in Escherichia Coli.
DOMPé FARMACEUTICI S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3United States;Italy