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A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

Primary Purpose

Immunologic Deficiency Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Immune Globulin Intravenous (Human)
Sponsored by
Grifols Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunologic Deficiency Syndrome focused on measuring Primary immune deficiency

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults and adolescents (age 13-75 inclusive) with a documented and confirmed pre-existing diagnosis of chronic primary immunodeficiency
  • Previously or currently on IgG replacement therapy
  • Documented (within 3 months) plasma IgG level of ≥500 mg/dL on current IgG therapy (IgG level can be obtained at the screening visit if documentation is not available)
  • The medical records for all subjects within the previous 2 years should be available to document previous infections and treatment

Exclusion Criteria:

  • Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial
  • The subject has a known adverse reaction to Gamunex or other blood products
  • The subject has a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections or other disorders where subcutaneous therapy would be contraindicated
  • The subject has known selective IgA deficiency with the exception of a known selective IgA deficient subject who has no previous documented eventful reaction to products containing IgA
  • The subject is pregnant or lactating
  • The subject has significant proteinuria and/or has a history of acute renal failure and/or severe renal impairment (BUN or creatinine more than 2.5 times the upper limit of normal) and/or on dialysis
  • The subject has known substance or prescription drug abuse in the past 12 months
  • The subject has a history of or current diagnosis of deep venous thrombosis
  • The subject has an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000 x 10e6/L), or HIV infection/AIDS
  • The subject is receiving any of the following medications: corticosteroids (long-term daily, >1 mg of prednisone equivalent/kg/day for >30 days) (intermittent courses would not exclude subject); immunosuppressants; or immunomodulators
  • The subject has non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg)
  • The subject has anemia (hemoglobin <10 g/dL) at screening
  • The subject has participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational blood product within the previous 3 months

Sites / Locations

  • University of California, Irvine
  • UCLA School of Medicine
  • Family Allergy & Asthma Center, PC
  • Allergy, Asthma & Immunology Associates, PC
  • Pediatric Allergy / Immunology Associates, PA
  • Virginia Commonwealth University
  • Dr. Donald F. Stark, Inc
  • McGill University - Montreal General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immune Globulin Intravenous (Human)

Arm Description

Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified

Outcomes

Primary Outcome Measures

Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)
Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).

Secondary Outcome Measures

Full Information

First Posted
October 17, 2006
Last Updated
March 31, 2015
Sponsor
Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00389324
Brief Title
A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency
Official Title
An Open-Label Single-Sequence, Crossover Trial to Evaluate the Pharmacokinetics and Safety of Subcutaneous Gamunex® 10% (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) in Subjects With Primary Immunodeficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grifols Therapeutics LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.
Detailed Description
This is an open-label, single-sequence, multi-center trial with subjects previously diagnosed with primary immune deficiency. Subjects will be on IGIV until a steady state is reached at which time PK profiling during the IV phase will occur. Subjects will begin SC administration 1 week following last IV dose and followed for a period of six months. PK profiling in SC phase will occur when subject reaches approximate steady-state on SC administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunologic Deficiency Syndrome
Keywords
Primary immune deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immune Globulin Intravenous (Human)
Arm Type
Experimental
Arm Description
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Intervention Type
Biological
Intervention Name(s)
Immune Globulin Intravenous (Human)
Other Intervention Name(s)
Gamunex, Gaminex, Immune globulin intravenous (Human)(IGIV), BAY 41-1000, TAL-05-00004, IGIV-C, IVIG, IGIVnex, NDC-13353-645-71, NDC-13353-646-24, NDC-13353-645-12, NDC-13353-645-15, NDC-13353-645-2
Intervention Description
This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months.
Primary Outcome Measure Information:
Title
Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)
Description
Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).
Time Frame
IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults and adolescents (age 13-75 inclusive) with a documented and confirmed pre-existing diagnosis of chronic primary immunodeficiency Previously or currently on IgG replacement therapy Documented (within 3 months) plasma IgG level of ≥500 mg/dL on current IgG therapy (IgG level can be obtained at the screening visit if documentation is not available) The medical records for all subjects within the previous 2 years should be available to document previous infections and treatment Exclusion Criteria: Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial The subject has a known adverse reaction to Gamunex or other blood products The subject has a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections or other disorders where subcutaneous therapy would be contraindicated The subject has known selective IgA deficiency with the exception of a known selective IgA deficient subject who has no previous documented eventful reaction to products containing IgA The subject is pregnant or lactating The subject has significant proteinuria and/or has a history of acute renal failure and/or severe renal impairment (BUN or creatinine more than 2.5 times the upper limit of normal) and/or on dialysis The subject has known substance or prescription drug abuse in the past 12 months The subject has a history of or current diagnosis of deep venous thrombosis The subject has an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000 x 10e6/L), or HIV infection/AIDS The subject is receiving any of the following medications: corticosteroids (long-term daily, >1 mg of prednisone equivalent/kg/day for >30 days) (intermittent courses would not exclude subject); immunosuppressants; or immunomodulators The subject has non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg) The subject has anemia (hemoglobin <10 g/dL) at screening The subject has participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational blood product within the previous 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Sorrells
Organizational Affiliation
Grifols Therapeutics LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Family Allergy & Asthma Center, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Allergy, Asthma & Immunology Associates, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Pediatric Allergy / Immunology Associates, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Dr. Donald F. Stark, Inc
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H3K2
Country
Canada
Facility Name
McGill University - Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.talecris-pi.info/inserts/gamunex.pdf
Description
FDA approved labeling information

Learn more about this trial

A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

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