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210507s2023 xx |||||o 00| ||eng c |
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|a (DE-627)CTG004644476
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|a (UBBS_Klinische_Studien_WHO)EUCTR2013-005099-17-LT
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|a (UBBS_Klinische_Studien_WHO)GTI1306
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|a A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.
|b A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis
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|c 2023
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|a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 25-05-2015, Last updated: 2023-06-29
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|a Medical Condition: Myasthenia Gravis MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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|a Study Type: Interventional
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|a Phase: Phase 2
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|a Recruitment Status: Not yet recruiting
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|a 610
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|t WHO International Clinical Trials Registry Platform
|g (2023) vom: 21. Juni
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|g year:2023
|g day:21
|g month:06
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