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

NCT00782106 | Completed Phase 1

• 1 other identifier: 160602
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary Immunodeficiency Diseases (PID)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Tolerability of subcutaneous infusions

Biological: Recombinant human hyaluronidase + immune globulin intravenous

2

EXPERIMENTAL

Tolerability of subcutaneous infusions and pharmacokinetics

Biological: Recombinant human hyaluronidase + immune globulin intravenous

Interventions

Recombinant human hyaluronidase + immune globulin intravenous BIOLOGICAL

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

Also known as: IGIV, 10% = Immune Globulin Intraveneous (Human), 10%, rHuPH20 = Recombinant Human Hyaluronidase

1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (3)

First Allergy and Clinical Research Center

Centennial, Colorado, 80112, United States

Location

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

Pediatrics Allergy/Immunology Association, PA

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

gamma-Globulins

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: December 4, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 5, 2021

Record last verified: 2021-04

Locations

US (3)