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) |
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| | 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 | | |
| 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] | | | | |
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. |
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| | 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 | | |
