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Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kedrion S.p.A.
ClinicalTrials.gov Identifier:
NCT01581593
First received: April 16, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).


Condition Intervention Phase
Primary Immunodeficiency
Agammaglobulinemia
Hypogammaglobulinemia
Antibody Deficiency
Biological: Kedrion IVIG 10%
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).

Resource links provided by NLM:


Further study details as provided by Kedrion S.p.A.:

Primary Outcome Measures:
  • Incidence of acute, serious bacterial infections [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, visceral abscess.


Secondary Outcome Measures:
  • Incidence of infections other than acute, serious bacterial infections [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    The incidence of infections other than acute serious bacterial infections.

  • Evidence of change in daily activities due to infections [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    • The number of days missed from work, school, kindergarten, day care, or days unable to perform normal daily activities due to infections.
    • Days of unscheduled physician visits and hospitalizations due to infection.
    • Days of therapeutic antibiotics.

  • IgG serum levels [ Time Frame: every month up to 13 months ] [ Designated as safety issue: No ]
    • IgG trough levels
    • Trough serum total IgG levels before each infusion of Kedrion IVIG 10% in all subjects and the interval between infusions will be recorded.

  • Incidence of adverse events [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    • Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product.
    • The proportion of adverse events considered by the investigator to be product related.

  • Incidence of decreased infusion rate due to adverse events [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    The proportion and number of IVIG infusions for which the infusion rate was decreased due to adverse events.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kedrion IVIG 10%
Kedrion IVIG 10% treatment.
Biological: Kedrion IVIG 10%
Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Duration - 12 months

Detailed Description:

People with primary immunodeficiency diseases (PID) have a defective immune system and experience recurrent protozoal, bacterial, fungal and viral infections. Antibody deficiencies make up the largest group of PIDs.

The standard care for patients with PID is replacement immunoglobulin (a class of antibodies) solution. Prophylactic treatment with intravenous immunoglobulin (IVIG) solution has been shown to increase the time free from serious infection.

Kedrion IVIG 10% is a new preparation of an immunoglobulin G (IgG) solution. Kedrion IVIG 10% will be given by IV infusion to all study participants. The data collected will help determine whether Kedrion IVIG 10% is suitable for treating PID subjects.

  Eligibility

Ages Eligible for Study:   2 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed clinical diagnosis of a Primary Immunodeficiency Disease
  • Male or female, ages 2 to 70 years
  • Received 300-900 mg/kg of a licensed IVIG therapy at 21 or 28 day intervals for at least 3 months prior to this study
  • 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months (one must be within 6 months) prior to study enrolment
  • Non-pregnant females of child-bearing potential who agree to use adequate birth control during the study
  • Subject is willing to comply with the protocol
  • Authorization to access personal health information.
  • Signed the informed consent form and a child assent form, if appropriate.
  • If currently participating in a clinical trial with another experimental IVIG may be enrolled if they have received stable IVIG therapy for at least 3 infusion cycles prior to receiving Kedrion IVIG 10% and all inclusion and exclusion criteria are satisfied
  • If currently participating in a trial of SCIG can be enrolled if they are switched to IVIG for three infusion cycles (21 or 28 days) prior to enrolment in this study

Exclusion Criteria:

  • Has secondary immunodeficiency.
  • Newly diagnosed and has not been treated with immunoglobulin or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency.
  • Has a history of repeated reactions or hypersensitivity to IVIG or other injectable forms of IgG.
  • Has a history of thrombotic events defined by at least 1 event in subject's lifetime.
  • Has IgA deficiency and is known to have antibodies to IgA.
  • Has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrolment.
  • Has significant protein losing enteropathy, nephrotic syndrome or lymphangiectasia.
  • Has an acute infection as documented by culture or diagnostic imaging and/or a body temperature exceeding 38.5 °C (101.3 °F) within 7 days prior to screening
  • Has a known history or is positive at enrolment for human immunodeficiency virus (HIV) type 1 by NAT, hepatitis B virus (HBsAg and NAT), hepatitis C virus (by NAT), or hepatitis A virus (by NAT).
  • Has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times of the upper limit of normal for the laboratory designated for the study.
  • Has an implanted venous access device
  • Has profound anemia or persistent severe neutropenia (≤ 1000 neutrophils per mm3)or lymphopenia of less than 500 cells per microliter.
  • Has a severe chronic condition such as renal failure (creatinine concentration > 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g. atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity, or any other condition that the investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.
  • Has a history of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to enrolment.
  • Has history of epilepsy or multiple episodes of migraine (defined as at least one episode within 6 months of enrolment) not completely controlled by medication.
  • Is receiving steroids (oral or parenteral daily dose of ≥ 0.15 mg/kg/day of prednisone or equivalent) OR other immunosuppressive drugs or chemotherapy.
  • Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study.
  • Has participated in another clinical study within 3 weeks prior to study enrolment.
  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: NCT01581593

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Florida
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States, 33408
United States, Georgia
Family Allergy & Asthma Center, PC
Atlanta, Georgia, United States, 30342
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Minnesota
Midwest Immunology Clinic
Plymouth, Minnesota, United States, 55446
United States, New York
AAIR Research Center
Rochester, New York, United States, 14618
United States, Ohio
Optimed Research, LTD
Columbus, Ohio, United States, 43235
United States, Texas
Dallas Allergy Immunology Research
Dallas, Texas, United States, 75230
AARA Research Center
Dallas, Texas, United States, 75231
United States, Virginia
Virginia Commonwealth University Health Systems
Richmond, Virginia, United States, 23298
United States, Washington
Marycliff Allergy Specialists
Spokane, Washington, United States, 99204
Canada, Ontario
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, Canada, M4V1R2
Pediatric & Adult Allergy & Clinical Immunology
Toronto, Ontario, Canada, M5G1E2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
Kedrion S.p.A.
Investigators
Study Director: Mirella Calcinai, MD Kedrion, SpA
  More Information

No publications provided

Responsible Party: Kedrion S.p.A.
ClinicalTrials.gov Identifier: NCT01581593     History of Changes
Other Study ID Numbers: KB052
Study First Received: April 16, 2012
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Kedrion S.p.A.:
Primary Immunodeficiency
PID
Agammaglobulinemia
Hypogammaglobulinemia
Antibody deficiency

Additional relevant MeSH terms:
Agammaglobulinemia
Immunologic Deficiency Syndromes
Blood Protein Disorders
Hematologic Diseases
Immune System Diseases
Lymphatic Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 20, 2014