Phase 3
N=38
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
Primary Immune Deficiency Disorders · Common Variable Immunodeficiency · X-linked Agammaglobulinaemia · Hyperimmunoglobulin M Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01884311 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: 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. — 0.98 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Subgam (Biological)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Bio Products Laboratory
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0.98 | — |
| SECONDARY Number of Participants Who Experienced AEs Based on Treatment-emergent AEs (TEAEs) |
36; 2; 1; 15; 23; 0 | — |
| SECONDARY Dose Refinement in Switching From Gammaplex 5% IGIV to Subgam-VF |
1.33 | — |
| SECONDARY Number of Infusion Site Reactions |
447 | — |
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.
Eligibility Criteria
Inclusion criteria
- Aged between 2 and 75 years (at time of initial consent).
- Body Mass Index (BMI) 0.15 mg of prednisone equivalent/kg/day). Requirement for short or intermittent courses of > 0.15mg/kg/day would not exclude a subject.
- Immunosuppressive drugs
- Immunomodulatory drugs
- If ≥ 18 years of age, has non-controlled arterial hypertension (systolic blood pressure > 160 mmHg &/or diastolic blood pressure > 100 mmHg). For younger subjects refer to current guidelines for diagnosis of blood pressure1.
- Has anemia (hemoglobin < 10 g/dL) at screening.
- Has severe dermatitis that would preclude sites for safe product administration.
Data sourced from ClinicalTrials.gov (NCT01884311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.