Primary Immunodeficiency Diseases (PID)
Conditions
Brief summary
The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.
Interventions
BIOLOGICALRecombinant human hyaluronidase + immune globulin intravenous
Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered
Sponsors
Baxalta now part of Shire
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent from either the subject or the subject's legally acceptable representative * Diagnosis of a PID disorder as defined by World Health Organization criteria1 for which the subject had been receiving a regimen of weekly or biweekly (every-other-week) subcutaneous IgG infusions or IGIV infusions every 21 to 28 days over a period of at least 8 weeks pre-study at an equivalent of a 4-week dose of 300 to 800 mg/kg bodyweight * Adults/adolescents aged 16 years and older) * For female subjects of child-bearing age: negative urine pregnancy test result at study entry and agreement to employ adequate birth control measures for the duration of the study
Exclusion criteria
* Subjects positive at enrollment for one or more of the following: HBsAg, PCR for HCV, PCR for HIV Type 1 * Subjects with levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory * Subjects with neutropenia (defined as an absolute neutrophil count \[ANC\] \<= 500/mm3). * Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender * Subjects with current history of malignancy * Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident) * Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease) * Subjects with anemia that in the opinion of the investigator precluded phlebotomy for laboratory studies * Subjects who had been exposed to any blood or blood product other than an intravenous immunoglobulin (IGIV), SC immunoglobulin (SCIG), immune serum globulin (ISG) preparations, or albumin within the 6 months prior to study entry. * Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SCIG and/or ISG infusions * Subjects with IgA deficiency and known anti IgA antibodies * Subjects who had received antibiotic therapy for the treatment of infection within 7 days prior to enrollment * Subjects who had participated in another clinical study involving an investigational product or device within 28 days prior to study entry * Subjects with inability or unwillingness to meet all the requirements of this study * If female, pregnancy or lactation at time of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to administer, after priming with recombinant human hyaluronidase, at least one half of a 4-week dose (minimum of 200 mg/kg) of IgG in a single infusion site, via the subcutaneous route, with no more than mild local adverse drug reactions. | 72 hours |
Countries
United States
Outcome results
None listed