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

NCT ID: NCT00782106

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-04
• Study Completion Date: 2007-11-01

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)

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Tolerability of subcutaneous infusions

Group Type: EXPERIMENTAL

Recombinant human hyaluronidase + immune globulin intravenous

Intervention Type: 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

2

Tolerability of subcutaneous infusions and pharmacokinetics

Group Type: EXPERIMENTAL

Recombinant human hyaluronidase + immune globulin intravenous

Intervention Type: BIOLOGICAL

1. IV infusion of IGIV, 10% to determine pharmacokinetics

2. Intervention as in Arm 1: 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

Interventions

Recombinant 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

Intervention Type: BIOLOGICAL

Recombinant human hyaluronidase + immune globulin intravenous

1. IV infusion of IGIV, 10% to determine pharmacokinetics

2. Intervention as in Arm 1: 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

Intervention Type: BIOLOGICAL

Other Intervention Names

IGIV; 10% = Immune Globulin Intraveneous (Human); 10%; rHuPH20 = Recombinant Human Hyaluronidase; IGIV; 10% = Immune Globulin Intraveneous (Human); 10%; rHuPH20 = Recombinant Human Hyaluronidase

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxalta now part of Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

Countries

United States

Other Identifiers

160602

Identifier Type: -

Identifier Source: org_study_id