Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases (NCT01884311) | Clinical Trial Compass
CompletedPhase 3
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
United States38 participantsStarted 2015-08-20
Plain-language summary
The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.
Who can participate
Age range2 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged between 2 and 75 years (at time of initial consent).
✓. Body Mass Index (BMI) \< 46 for adults (aged 16 years \& older), \& BMI \< 28 for children.
✓. Diagnosed with primary immunodeficiency disease e.g. common variable immunodeficiency, X-linked \& autosomal forms of agammaglobulinaemia, hyper-IgM syndrome, Wiskott-Aldrich syndrome.
✓. Currently receiving a licensed (or investigational stage III, IIIb) IGIV or SCIG and
✓. IGIV dose is between 300 and 800 mg/kg/month. SCIG dose is between 110 \& 300 mg/kg/week;
✓. Dose is stable for at least the past three months (i.e. consistent mg/kg +/- 5%);
✓. The infusion interval is every 21 or 28 days for IGIV \& seven days for SCIG;
✓. Has a documented trough level of ≥ 6 g/L (600 mg/dL) on current IgG therapy. If not available can be obtained at the screening visit, Visit 1 (Week 0).
Exclusion criteria
✕. Has a history of any severe anaphylactic reaction to blood or any blood-derived product.
✕. Has selective IgA deficiency or has a history of antibodies to IgA.
✕. Has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
✕. Has evidence of an active infection at the time of enrolment (i.e. on day of first infusion). Subjects who are asymptomatic but have not completed their course of antibiotics are eligible.
What they're measuring
1
Data (Derived From Absolute Concentration) Were Pooled With Historical Data and a Treatment Variable Defined (Subgam-VF or Gammaplex 5% IGIV). Outcome Measure Defined as Log Transformed sAUC0-t Standardized to One Week.
✕. Has previously completed or withdrawn from this study.
✕. Is currently receiving, or has received, any investigational agent within the prior three months, unless it is an investigational stage III, IIIb IGIV or SCIG.
✕. Is pregnant (confirmed by a positive result on an HCG-based pregnancy test) or is nursing.
✕. Is positive for any of the following at screening: