CompletedPhase 3

A Clinical Study of Intravenous Immunoglobulin

United States, Canada57 participantsStarted 2006-11

Plain-language summary

The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) \[IGIV\], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.

Who can participate

Age range

3 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

The following list is incomplete. A complete list is in the protocol. Inclusion Criteria: * Ages 3 to 75 years and weigh at least 27 kg. * Confirmed clinical diagnosis of a Primary Immune Deficiency disease including hypogammaglobulinemia, preferably with documented antibody deficiency, or agammaglobulinemia. * Has been receiving licensed IGIV for at least 3 months prior to this study. * Trough IgG levels, dose of IGIV, and treatment intervals for the last 2 consecutive licensed IGIV treatments must be documented. * The subject or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form. * The subject or legal representative has signed the HIPAA declaration. Exclusion Criteria: * Subjects with isolated IgG subclass deficiency or specific antibody deficiency without hypogammaglobulinemia will not be eligible. * The subject has a history of hypersensitivity or persistent or repeated adverse reactions to human immunoglobulin. * The subject has selective IgA deficiency, history of reaction to products containing IgA, or is known to have antibodies to IgA. * The subject is currently participating, or has participated within the previous 30 days, in another clinical study of an investigational product or device. * The subject is pregnant or is nursing. Women of childbearing potential must agree to using a method of contraception. * The subject has had an acute bacterial infection within 28 days of screening. * The subject i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of acute serious bacterial infections

Timeframe: one year

Trial details

NCT IDNCT00468273

SponsorFFF Enterprises

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-05

View on ClinicalTrials.gov More Immunologic Deficiency Syndromes trials

Who can participate

Age range

3 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.