CompletedPhase 3

Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

United States50 participantsStarted 2006-01

Plain-language summary

The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.

Who can participate

Age range3 Years

SexALL

See this in plain English?

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

Exclusion criteria

✕. The subject has a history of any severe anaphylactic reaction to blood or any blood-derived product.
✕. The subject is known to be intolerant to any component of GAMMAPLEX, such as sorbitol (i.e.(id est / that is) , intolerance to fructose).
✕. The subject has selective immunoglobulin A (IgA) deficiency, history of reaction to products containing IgA, or has a history of antibodies to IgA.
✕. Subjects who have completed the study and subjects who have withdrawn cannot participate in the study for a second time.
✕. The subject is currently receiving, or has received, any investigational agent, other than an immune serum globulin (ISG) preparation that is being evaluated in a Phase III or IIIb study, within the prior 3 months.
✕. The subject has been exposed to blood or any blood product or derivative within the last 6 months, other than a commercially available IGIV or other forms of commercially available and licensed ISG or an ISG product that is in Phase III or IIIb studies.
✕. The subject is pregnant or is nursing.
✕. The subject is positive for any of the following at screening:

What they're measuring

Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease.

Timeframe: 12 months

Trial details

NCT IDNCT00278954

SponsorBio Products Laboratory

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-11

Results submitted2009-05-29

View on ClinicalTrials.gov More Primary Immunodeficiency trials