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

NCT01581593 | Completed Phase 3 Results DMC

• 1 other identifier: KB052
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Primary Immunodeficiency; Agammaglobulinemia; Hypogammaglobulinemia; Antibody Deficiency

Keywords

Primary Immunodeficiency; PID; Agammaglobulinemia; Hypogammaglobulinemia; Antibody deficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of Acute, Serious Bacterial Infections in the Total ITT Population.

  The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis, meeting EMA and FDA criteria.

  13 months

Secondary Outcomes (14)

• Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population.

  13 months

• Days Out of Work/School/Daycare Due to Infection in the Total ITT Population.

  13 months

• Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population.

  13 months

• Days on Therapeutic Antibiotics in the Total ITT Population.

  13 months

• Days of Unscheduled Visits to Physicians in the Total ITT Population.

  13 months

Study Arms (1)

Kedrion IVIG 10%

EXPERIMENTAL

Kedrion IVIG 10% treatment.

Biological: Kedrion IVIG 10%

Interventions

Kedrion IVIG 10% BIOLOGICAL

Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months

Kedrion IVIG 10%

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Kedrion S.p.A.: lead

Study Sites (15)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

Family Allergy & Asthma Center, PC

Atlanta, Georgia, 30342, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Midwest Immunology Clinic

Plymouth, Minnesota, 55446, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

Dallas Allergy Immunology Research

Dallas, Texas, 75230, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

Virginia Commonwealth University Health Systems

Richmond, Virginia, 23298, United States

Location

Marycliff Allergy Specialists

Spokane, Washington, 99204, United States

Location

Gordon Sussman Clinical Research Inc.

Toronto, Ontario, M4V1R2, Canada

Location

Pediatric & Adult Allergy & Clinical Immunology

Toronto, Ontario, M5G1E2, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Agammaglobulinemia

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases

Results Point of Contact

• Title: Dr. Mirella Calcinai, MD, Clinical Research Director
• Organization: Kedrion S.p.A

m.calcinai@kedrion.com

+393486559761

Study Officials

• Mirella Calcinai, MD

  Kedrion SpA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 20, 2012
• Study Start: November 12, 2012
• Primary Completion: August 27, 2014
• Study Completion: August 27, 2014
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (12)