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

Completed · Phase 3

Conditions studied: Primary Immunodeficiency Diseases

In brief

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.

Key facts

Study ID

NCT01012323

Run by

Octapharma

People needed

51

Starts

2010-01-01

Expected to finish

2012-06-01

Last updated by the study team

2017-03-16

Who can join

Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of ≥ 2 years and ≤ 75 years.
• Confirmed diagnosis of common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA).
• Previously treated with a commercial immune globulin intravenous (human) every 21-28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight.

You may not qualify if…

• Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
• Exposure to blood or any blood product or derivative, other than commercially available intravenous immunoglobulin (IVIG), within the past 3 months prior to enrollment.
• Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, 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 of normal).
• Presence of renal function impairment (creatinine > 120 μmol/L), or predisposition for acute renal failure (eg, any degree of pre-existing renal insufficiency or routine treatment 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 diastolic blood 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: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV).
• Treatment with steroids (oral or parenteral, long-term, ie, 30 days or more, not intermittent 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 chemicals within the past 12 months prior to enrollment.
• Pregnant or nursing women.

Where it is running

• Sudir Gupta, MD — Irvine, California, United States
• Isaac Melamed, MD — Centennial, Colorado, United States
• James Moy, MD — Chicago, Illinois, United States
• William Smits, MD — Fort Wayne, Indiana, United States
• Dr. Alan Knutsen — St Louis, Missouri, United States
• Ai Lan Kobayashi, MD — Papillion, Nebraska, United States
• Hans Ochs, MD — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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