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

Primary Purpose

Primary Immunodeficiency Diseases (PID)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Recombinant human hyaluronidase + immune globulin intravenous
Recombinant human hyaluronidase + immune globulin intravenous
Sponsored by
Baxalta now part of Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immunodeficiency Diseases (PID)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First Allergy and Clinical Research Center
  • Allergy Associates of the Palm Beaches
  • Pediatrics Allergy/Immunology Association, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Tolerability of subcutaneous infusions

Tolerability of subcutaneous infusions and pharmacokinetics

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2008
Last Updated
April 30, 2021
Sponsor
Baxalta now part of Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00782106
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2006 (Actual)
Primary Completion Date
November 1, 2007 (Actual)
Study Completion Date
November 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency Diseases (PID)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tolerability of subcutaneous infusions
Arm Title
2
Arm Type
Experimental
Arm Description
Tolerability of subcutaneous infusions and pharmacokinetics
Intervention Type
Biological
Intervention Name(s)
Recombinant human hyaluronidase + immune globulin intravenous
Other Intervention Name(s)
IGIV, 10% = Immune Globulin Intraveneous (Human), 10%, rHuPH20 = Recombinant Human Hyaluronidase
Intervention Description
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
Intervention Name(s)
Recombinant human hyaluronidase + immune globulin intravenous
Other Intervention Name(s)
IGIV, 10% = Immune Globulin Intraveneous (Human), 10%, rHuPH20 = Recombinant Human Hyaluronidase
Intervention Description
IV infusion of IGIV, 10% to determine pharmacokinetics 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
Primary Outcome Measure Information:
Title
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
First Allergy and Clinical Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Allergy Associates of the Palm Beaches
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Pediatrics Allergy/Immunology Association, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

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

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