Clairyg (intravenous normal human immunoglobulin) / LFB SA  >>  Phase 3
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8 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Clairyg (intravenous normal human immunoglobulin) / LFB SA
2012-001996-34: A comparative, double-blind, randomised, multicentre efficacy and safety study of ClairYg® versus Tégéline® in maintenance treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Ongoing
3
44
Europe
CLAIRYG 50 mg/ml, TEGELINE 50mg/ml, Solution for infusion, Powder and solvent for solution for injection, CLAIRYG 50mg/ml, TEGELINE 50mg/ml
LFB BIOTECHNOLOGIES, LFB BIOTECHNOLOGIES
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Diseases [C] - Nervous System Diseases [C10]
 
 
2011-001354-29: An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)

 
3
10
Europe
HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE, I10E,
LFB BIOTECHNOLOGIES, LFB BIOTECHNOLOGIES
ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
 
05/13
NCT01951924 / 2012-001995-12: LIME Study (LFB IVIg MMN Efficacy Study)

Completed
3
23
Europe
Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL), Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Laboratoire français de Fractionnement et de Biotechnologies, TFS Trial Form Support
Motor Neuron Disease
07/16
07/16
PRISM2, NCT02317562 / 2013-005558-31: Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302

Terminated
3
19
Europe, RoW
I10E
Laboratoire français de Fractionnement et de Biotechnologies
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
07/17
07/17
PRISM, NCT02293460 / 2013-005557-73: Efficacy and Safety Study of I10E in Treatment of Patients With CIDP

Completed
3
44
Europe, RoW
I10E
Laboratoire français de Fractionnement et de Biotechnologies
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
09/17
09/17
2019-004433-17: Kawasaki Disease Coronary Artery Aneurysm Prevention trial

Ongoing
3
262
Europe
Prednisolone (Tablet 1mg), Prednisolone (Soluble Tablet 5mg), Prednisolone (Oral Solution 10mg/ml), Human Normal Immunoglobulin (IVIg 100mg/ml), Aspirin (Dispersible Tablet 75mg), Aspirin (Tablets 300mg), Prednisolone (Tablet 5mg), Prednisolone (Tablet 10mg), Prednisolone (Tablet 2.5mg), Prednisolone (Tablet 20mg), Prednisolone (Tablet 25mg), Prednisolone (Tablet 30mg), Methylprednisolone (500mg), Methylprednisolone (1000mg), Human Normal Immunoglobulin (IVIg 50mg/ml), Aspirin (Tablet 75mg), Methylprednisolone (40mg), Methylprednisolone (125mg), Methylprednisolone (2g), B01AC06, Tablet, Soluble tablet, Oral solution, Solution for injection/infusion, Dispersible tablet, Powder and solvent for solution for injection/infusion, Powder for injection, Asaflow (80mg), Aspirine (100mg), Aspegic 100mg, Cardioaspirine (100mg), Solu-Medrol S.A.B. (40mg), Octagam (50 mg/ml) solution for infusion, Octagam 10% solution for infusion, Privigen 100 mg/ml solution for infusion, Iqymune (100mg/mL), Okrido 6mg/ml drank
MRC CTU at UCL, Medical Research Council Clinical Trials Unit at University College London, UNIVERSITY COLLEGE LONDON, MRC Clinical Trials Unit at University College London (UCL), Innovative Medicines Initiative 2 Joint Undertaking, Innovative Medicines Initiative 2, Innovative Medicine Initiative 2 Joint Undertaking
Kawasaki Disease, Kawasaki Disease, Diseases [C] - Cardiovascular Diseases [C14]
 
 
ICAR, NCT04350580 / 2020-001570-30: Polyvalent Immunoglobulin in COVID-19 Related ARds

Completed
3
146
Europe
Human immunoglobulin, Clairyg, Placebo, Sodium chloride 0.9%
Centre Hospitalier St Anne, Groupe Hospitalier Universitaire Paris psychiatrie & neurosciences, Laboratoire français de Fractionnement et de Biotechnologies
Acute Respiratory Distress Syndrome, COVID-19
11/20
02/21
2010-023483-41: A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune system A primer immundeficiencia olyan állapot, melynek oka egy genetikai hiány. A szervezet nem képes elég antitestet termelni, ezért képtelen a baktériumok és vírusok ellen küzdeni. A fertőzések állandóan visszatérnek, főleg a légutakat, az orrüregeket és a füleket, az ízületeket és az emésztőszerveket is érintik. 3-4 hetente adott kezelés biztosítja az antitesteket a betegeknek. Az I10E nagyon biztonságos, mert gyártása két, a vírusok hatástalanítását/eltávolítását célzó folyamatot foglal magában.

 
2/3
25
Europe
HUMAN NORMAL IMMUNOGLOBULIN FOR, I10E,
LFB BIOTECHNOLOGIES, LFB BIOTECHNOLOGIES,
a primary immunodeficiency as defined by the ESID and validated by a reference centre : • X-linked agammaglobulinemia (XLA) • Common variable immunodeficiency (CVID)
 
03/13

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