Last updated on May 2018

Phase III Efficacy Safety and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP


Brief description of study

This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks) of IGIV therapy for at least 12 weeks prior to screening. In this double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6 months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for a period of 6 months.

Clinical Study Identifier: NCT02549170

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Fakultni nemocnice Ostrava
Ostrava - Poruba, Czech Republic
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Bordeaux Cedex, France
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IRCCS Ospedale Casa Sollievo della Sofferenza
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Pozzilli, Italy
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Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, Italy
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Pisa, Italy
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Madrid, Spain
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Valencia, Spain
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Goteborg, Sweden
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251 General Air Force Hospital
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Athens Medical Center
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Milano, Italy
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Udine, Italy
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Oslo, Norway
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Belgrade, Serbia
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Nis, Serbia
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Nitra, Slovakia
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Konya, Turkey
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Bristol, United Kingdom
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Linz, Austria
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