Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously

Baxalta

Status and phase

Completed

Phase 2

Phase 1

Conditions

Primary Immunodeficiency Diseases (PID)

Treatments

Biological: Recombinant human hyaluronidase + immune globulin intravenous

Study type

Interventional

Funder types

Industry

Identifiers

NCT00782106

160602

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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