A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases

Last updated: February 8, 2017
Sponsor: Octapharma
Overall Status: Completed

Phase

3

Condition

Primary Immunodeficiency Disorders

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT01012323
NGAM-01
2009-011434-10
  • Ages 2-75
  • All Genders

Study Summary

The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of NewGam and its effect on quality of life were also evaluated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age of ≥ 2 years and ≤ 75 years.

  • Confirmed diagnosis of common variable immunodeficiency (CVID) or X-linkedagammaglobulinemia (XLA).

  • Previously treated with a commercial immune globulin intravenous (human) every 21-28days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kgbody weight.

Exclusion

Exclusion Criteria:

  • Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to andduring the screening period.

  • Exposure to blood or any blood product or derivative, other than commerciallyavailable intravenous immunoglobulin (IVIG), within the past 3 months prior toenrollment.

  • Ongoing history of hypersensitivity or persistent reactions to blood or plasma derivedproducts, or any component of the investigational product.

  • Requirement of any routine pre-medication for IVIG infusion.

  • Severe liver function impairment (alanine aminotransferase [ALAT] 3x > upper limit ofnormal).

  • Presence of renal function impairment (creatinine > 120 μmol/L), or predisposition foracute renal failure (eg, any degree of pre-existing renal insufficiency or routinetreatment with known nephritic drugs).

  • History of autoimmune hemolytic anemia.

  • History of diabetes mellitus.

  • Congestive heart failure New York Heart Association (NYHA) class III or IV.

  • Non-controlled arterial hypertension (systolic blood pressure > 160 mmHg or diastolicblood pressure > 90 mmHg).

  • History of deep vein thrombosis or thrombotic complications of IVIG therapy.

  • A positive result at screening on any of the following viral markers: humanimmunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV).

  • Treatment with steroids (oral or parenteral, long-term, ie, 30 days or more, notintermittent or burst, daily, ≥ 0.15 mg of prednisone or equivalent/kg/day),immunosuppressive or immunomodulatory drugs.

  • Planned vaccination during the study period.

  • Treatment with any investigational agent within 3 months prior to enrollment.

  • Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicalswithin the past 12 months prior to enrollment.

  • Pregnant or nursing women.

Study Design

Total Participants: 51
Study Start date:
January 01, 2010
Estimated Completion Date:
June 30, 2012

Study Description

NewGam is a new 10% human normal immunoglobulin (IVIG) solution developed by Octapharma for intravenous administration. It is supplied as a liquid formulation ready to use. The primary therapeutic use of immunoglobulins is to provide antibodies to prevent viral and bacterial diseases (replacement therapy). IVIG has proved to be useful in a variety of clinical conditions other than for replacement of immunoglobulins; IVIG exhibits an immunomodulatory effect. Children and adults with a Primary Immunodeficiency Disease (PID) have an increased risk of recurrent bacterial and viral infections that typically attack the respiratory tract (sinusitis, bronchitis, pneumonia) but can also affect the gastrointestinal tract (gastroenteritis). Theses diseases can be severe and can lead to substantial morbidity. Responses to antibacterial therapy are often poor. At present, most primary immune deficiencies are not curable, but IVIGs have been shown to decrease the total number of severe infections and the duration of hospitalization.

Connect with a study center

  • Sudir Gupta, MD

    Irvine, California
    United States

    Site Not Available

  • Isaac Melamed, MD

    Centennial, Colorado
    United States

    Site Not Available

  • James Moy, MD

    Chicago, Illinois
    United States

    Site Not Available

  • William Smits, MD

    Fort Wayne, Indiana
    United States

    Site Not Available

  • Dr. Alan Knutsen

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Ai Lan Kobayashi, MD

    Papillion, Nebraska
    United States

    Site Not Available

  • Hans Ochs, MD

    Seattle, Washington
    United States

    Site Not Available

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