Gammagard Liquid and rHuPH20 in PID

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00814320
First received: December 23, 2008
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

The purpose of the study is to develop a subcutaneous treatment option for subjects with PID that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.


Condition Intervention Phase
Primary Immunodeficiency Diseases (PID)
Biological: Recombinant human hyaluronidase + immune globulin intravenous
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • The primary endpoint is the validated acute serious bacterial infection rate, defined as the mean number of validated acute serious bacterial infections per subject per year in the intent-to-treat population. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: December 2008
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Efficacy and tolerability of SC infusions
Biological: Recombinant human hyaluronidase + immune globulin intravenous

Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (SC infusions) as bioavailability/exposure for IV treatment was already obtained in Study 160601.

Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment.

Experimental: 2
Pharmacokinetics of IV treatment and efficacy and tolerability of SC infusions
Biological: Recombinant human hyaluronidase + immune globulin intravenous

Comprises all other subjects.

Study Epoch 1: IV infusion of IGIV, 10% (same dose and frequency as pre-study) to determine pharmacokinetics.

Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment.


  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is 2 years or older at the time of screening
  • Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
  • Subject has been diagnosed with a PID disorder requiring antibody replacement as defined by WHO criteria
  • Subject has completed or is about to complete Baxter Clinical Study Protocol No. 160601 or has been receiving a regular IGIV-treatment at mean intervals of 21 ± 3 days or 28 ± 3 days, or SC at mean intervals of 5 to 16 days, over a period of at least 3 months prior to enrollment at a minimum dose of 300 mg/kg BW/4 weeks
  • Subject has a serum trough level of IgG > 4.5 g/L at the last documented determination
  • If female of childbearing potential, subject presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Subject is positive at enrollment or screening for one or more of the following: Hepatitis B surface antigen (HbsAg), polymerase chain reaction (PCR) for Hepatitis C Virus (HCV), PCR for Human immunodeficiency virus (HIV) Type 1/2
  • Subject has levels of alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory
  • Subject has persistent severe neutropenia (defined as an absolute neutrophil count [ANC] <= 500/mm3)
  • Subject has creatinine clearance values, calculated according to the formula below, which are < 60% of normal for age and gender for males: CLcr = [(140 - Age(years)) * (body weight (kg))] / [72 * (Serum Creatinine (mg/dL))] for females: CLcr = [(140 - Age(years)) * (body weight(kg)) * 0.85] / [72 * (Serum Creatinine (mg/dL))]
  • Subject has malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Subject has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months
  • Subject has abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
  • Subject has anemia that would preclude phlebotomy for laboratory studies
  • Subject has received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment
  • Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin, and/or ISG infusions
  • Subject has immunoglobulin A (IgA) deficiency and known anti IgA antibodies
  • Subject is on preventative (prophylactic) antibiotics and cannot stop antibiotics at the time of enrollment
  • Subject has active infection who started on antibiotic therapy for the treatment of infection within 7 days prior to screening
  • Subject has a bleeding disorder or are on anti-coagulation therapy
  • Subject has total protein > 9 g/dL and subjects with myeloma, macroglobulinemia (IgM) and paraproteinemia
  • Subject has a known allergy to hyaluronidase
  • If female, subject is pregnant or lactating at the time of study enrollment
  • Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study; exception: Baxter Study No. 160601
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814320

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90360
University of California, Irvine
Irvine, California, United States, 92697
Children´s Hospital Los Angeles, Division of Clinical Immunology & Allergy
Los Angeles, California, United States, 90027
UCLA Schoold of Medicine / UCLA Medical Center, Dept. of Pediatrics
Los Angeles, California, United States, 90095
University of California
San Francisco, California, United States, 94143
United States, Colorado
IMMUNOe International Research Centers
Centennial, Colorado, United States, 80112
United States, Florida
Allergy Associates of the Palm Beaches, P.A.
North Palm Beach, Florida, United States, 33408
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Allergy and Asthma Physicians
Hinsdale, Illinois, United States, 60521
United States, Nebraska
Allergy Asthma & Immunology Associates
Omaha, Nebraska, United States, 68124
United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Texas
Dallas Allergy Immunology Research, 7777 Forest Lane, Suite B-332
Dallas, Texas, United States, 75230
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0561
Canada, British Columbia
St. Paul´s Hospital, Pacific Lung Health Centre
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Baxter BioScience Investigator, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Richard Schiff, MD, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00814320     History of Changes
Other Study ID Numbers: 160603
Study First Received: December 23, 2008
Last Updated: November 30, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014