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Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases (GMX07)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory
ClinicalTrials.gov Identifier:
NCT01963143
First received: September 13, 2013
Last updated: February 10, 2017
Last verified: February 2017
  Purpose

The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects.

The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.


Condition Intervention Phase
Primary Immune Deficiency Disorders Common Variable Immunodeficiency X-linked Agammaglobulinaemia Hyper-IgM Syndrome Biological: Gammaplex (5%) Biological: Gammaplex 10 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

Resource links provided by NLM:


Further study details as provided by Bio Products Laboratory:

Primary Outcome Measures:
  • Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects [ Time Frame: After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion ]

Secondary Outcome Measures:
  • Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects [ Time Frame: After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion ]
  • Secondary Bioequivalence Analysis - IgG Trough Levels [ Time Frame: After a minimum 5 infusions on each product, at pre-infusion. ]

Enrollment: 48
Study Start Date: February 2014
Study Completion Date: May 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence 1 - Adults
Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Biological: Gammaplex (5%) Biological: Gammaplex 10
Experimental: Treatment Sequence 2 - Adults
Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Biological: Gammaplex (5%) Biological: Gammaplex 10
Experimental: Pediatrics
Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Biological: Gammaplex 10

  Eligibility

Ages Eligible for Study:   2 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Adult cohort: The subject is aged 16 to 55 years inclusive, is of either sex, and belongs to any ethnic group.

    Pediatric cohort: The subject is aged 2 to 15 years inclusive, is of either sex, weighs at least 10 kg, and belongs to any ethnic group.

  2. The subject has primary immunodeficiency disease, e.g. common variable immunodeficiency, X linked and autosomal forms of agammaglobulinemia, hyper IgM (Immunoglobulin M) syndrome. Isolated deficiency of a single IgG subclass or of specific antibodies without hypogammaglobulinemia per se, does not qualify for inclusion.
  3. The subject is currently receiving a licensed IGIV (or investigational stage III, IIIb IGIV) at a dose that has not changed by ± 50% of the mean dose for at least three months before study entry and is between 300 and 800 mg/kg/infusion. The infusion interval must be either every 21 or every 28 days.
  4. The subject must have a trough level ≥ 6 g/L (600 mg/dL). At least one documented trough level must be available from the three months before Screening.
  5. The subject must have documentation from the last three consecutive routine IGIV infusions for the following, before the first infusion in this study: dose of IGIV, treatment intervals, and trade name (or identity) of the IGIV treatment.
  6. Female subjects of childbearing potential must have a negative result on an HCG (human chorionic gonadotropin) based pregnancy test at Screening.
  7. Females who are or become sexually active must practice contraception using a method of proven reliability for the study duration.
  8. The subject is willing to comply with all aspects of the protocol for the duration of the study.
  9. The subject has signed an informed consent form and assent form (if applicable).

Exclusion criteria:

  1. The subject has a history of any severe anaphylactic reaction to blood or any blood derived product.
  2. The subject has selective IgA deficiency, history of reaction to products containing IgA (Immunoglobulin A), or has a history of antibodies to IgA.
  3. The subject has cellular or innate impaired immunity (i.e. only subjects with humoral impaired immunity may be included).
  4. The subject has evidence of an active infection at the time of enrolment.
  5. The subject has previously completed or withdrawn from this study.
  6. The subject is currently receiving, or has received, any investigational agent other than an IGIV within the prior three months.
  7. The subject is pregnant or is nursing.
  8. The subject has positive results for any of the following at Screening:

    • Serological test for HIV 1 and 2, HCV, or HBsAg
    • NAT (Nucleic acid amplification technique)for HCV
    • NAT for HIV
  9. The subject has levels > 2.5 times the upper limit of normal, as defined at the central laboratory, of any of the following at Screening:

    • Alanine amino transaminase
    • Aspartate amino transaminase
  10. The subject has severe renal impairment (defined as serum creatinine greater than two times the upper limit of normal or blood urea nitrogen greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); the subject is on dialysis; the subject has a history of acute renal failure.
  11. The subject is known to abuse alcohol, opiates, psychotropic agents, or other chemicals or drugs, or has done so within the past 12 months.
  12. The subject has a history of deep vein thrombosis or thrombotic complications of IGIV therapy.
  13. The subject suffers from any acute or chronic* medical condition (e.g. renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing state) that the Investigator feels may interfere with the conduct of the study.
  14. The subject has an acquired immunodeficiency condition such as chronic* lymphocytic leukemia, lymphoma, multiple myeloma, or chronic or recurrent neutropenia (absolute neutrophil count < 1 × 109/L).
  15. The subject is receiving the following medication:

    • Steroids (long term daily, ≥ 0.15 mg of prednisone equivalent/kg/day). Requirement for short or intermittent courses of steroids would not exclude a subject.
    • Immunosuppressive drugs
    • Immunomodulatory drugs
  16. The subject has uncontrolled arterial hypertension (systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg).
  17. The subject has anemia (hemoglobin < 10 g/dL) at Screening.
  18. The subject is known to be intolerant to any component of Gammaplex, such as sorbitol (i.e. hereditary intolerance to fructose) or glycine.

    • Chronic conditions would be as per the Investigator's opinion however for this study the guidance is that the condition has been present for at least 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963143

Locations
United States, Arizona
Arizona Allergy Associates
Chandler, Arizona, United States, 85224
United States, California
Miller Children's Hospital
Long Beach,, California, United States, 90806
UCLA Medical Center
Los Angeles,, California, United States, 90095
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
IMMUNOe International Research Centers
Centennial, Colorado, United States, 80112
United States, Florida
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Allergy Associates of the Palm Beaches, PA
N Palm Beach, Florida, United States, 33408
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States, 20815
United States, Ohio
Asthma and Allergy Center
Toledo, Ohio, United States, 43617
United States, Texas
Dallas Allergy Immunology Research
Dallas, Texas, United States, 75230
United States, Utah
University of Utah Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Virginia
O&O Alpan, LLC
Fairfax,, Virginia, United States, 22030
United States, Washington
Bellingham Asthma Allergy and Immunology Clinic
Bellingham, Washington, United States, 98225
Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz
Budapest, Hungary
United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
The Royal Free Hospital and Medical School
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Bio Products Laboratory
Investigators
Study Director: Eric Wolford Bio Products Laboratory
  More Information

Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT01963143     History of Changes
Other Study ID Numbers: GMX07
Study First Received: September 13, 2013
Results First Received: February 10, 2017
Last Updated: February 10, 2017

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Common Variable Immunodeficiency
Agammaglobulinemia
Hyper-IgM Immunodeficiency Syndrome
Hyper-IgM Immunodeficiency Syndrome, Type 1
Genetic Diseases, X-Linked
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Dysgammaglobulinemia
Genetic Diseases, Inborn
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017