Clinical trial NCT00782106: Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously
Official title: Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Immunodeficiency Diseases (PID)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 11
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Centennial
country: United States
facility: First Allergy and Clinical Research Center
state: Colorado
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: Dallas
country: United States
facility: Pediatrics Allergy/Immunology Association, PA
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: