Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously
Phase 1
Completed
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- Biological: Recombinant human hyaluronidase + immune globulin intravenous
- Registration Number
- NCT00782106
- Lead Sponsor
- Baxalta now part of Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Recombinant human hyaluronidase + immune globulin intravenous Tolerability of subcutaneous infusions 2 Recombinant human hyaluronidase + immune globulin intravenous Tolerability of subcutaneous infusions and pharmacokinetics
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
First Allergy and Clinical Research Center
🇺🇸Centennial, Colorado, United States
Allergy Associates of the Palm Beaches
🇺🇸North Palm Beach, Florida, United States
Pediatrics Allergy/Immunology Association, PA
🇺🇸Dallas, Texas, United States