Efficacy, safety, tolerability and pharmacokinetics of a novel human immune globulin subcutaneous, 20%: a Phase 2/3 study in Europe in patients with primary immunodeficiencies

Clinical and Experimental Immunology

Volumn 187, Issue 1, 2017, Pages 146-159

  Borte, M ^a   Krivan G ^b   Derfalvi, B ^c,d   Marodi L ^e   Harrer, T ^f   Jolles, S ^g   Bourgeois, C ^h   Engl, W ^h   Leibl, H ^h   McCoy, B ⁱ   Gelmont, D ^j   Yel, L ^i,k  

^a Klinikum St Georg   (Germany)

^b Szent Laszlo Hospital   (Hungary)

^c SEMMELWEIS UNIVERSITY   (Hungary)

^d DALHOUSIE UNIVERSITY   (Canada)

^e UNIVERSITY OF DEBRECEN   (Hungary)

^f UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^g UNIVERSITY HOSPITAL OF WALES   (United Kingdom)

^h Baxalta Innovations GmbH   (Austria)

ⁱ SHIRE   (United States)

^j Baxalta US Inc   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

20 immunoglobulin; immunoglobulin replacement therapy; pharmacokinetics; primary immunodeficiency diseases; subcutaneous administration

Indexed keywords

ANTIBIOTIC AGENT; HEMOGLOBIN; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN;

ABDOMINAL PAIN; ACUTE HEART INFARCTION; ADOLESCENT; ADULT; AGED; ARTICLE; AUTOSOMAL RECESSIVE DISORDER; BACTERIAL INFECTION; BACTERIAL PNEUMONIA; BRAIN STEM INFARCTION; BRONCHITIS; CHILD; CHRONIC SINUSITIS; CLINICAL ARTICLE; COMMON VARIABLE IMMUNODEFICIENCY; DIARRHEA; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENTERITIS; EUROPE; FATIGUE; FEMALE; FOREARM FRACTURE; HEADACHE; HEART VENTRICLE FIBRILLATION; HEMOLYSIS; HOME CARE; HOSPITALIZATION; HUMAN; HUMORAL IMMUNE DEFICIENCY; HYPER IGM SYNDROME; HYPOTENSION; IMMUNE DEFICIENCY; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOGLOBULIN DEFICIENCY; IMMUNOGLOBULIN G DEFICIENCY; IMMUNOGLOBULIN M DEFICIENCY; INCIDENCE; INFLUENZA; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; INJECTION SITE URTICARIA; LYMPHADENOPATHY; LYMPHOCYTE PROLIFERATION; MALE; MULTICENTER STUDY; NOSE DISEASE; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RECOMMENDED DRUG DOSE; RHINORRHEA; SPINE FRACTURE; SUBSTITUTION THERAPY; VALIDATED ACUTE BACTERIAL INFECTION; X LINKED AGAMMAGLOBULINEMIA; CLINICAL TRIAL; FOLLOW UP; IMMUNOLOGIC DEFICIENCY SYNDROMES; MIDDLE AGED; PRESCHOOL CHILD; SUBCUTANEOUS DRUG ADMINISTRATION; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; CHILD; CHILD, PRESCHOOL; EUROPE; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC DEFICIENCY SYNDROMES; INFUSIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; YOUNG ADULT;

EID: 84995489910     PISSN: 00099104     EISSN: 13652249     Source Type: Journal    
DOI: 10.1111/cei.12866     Document Type: Article

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