Phase 4
N=18
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
Common Variable Immunodeficiency · Agammaglobulinemia
Bottom Line
View on ClinicalTrials.gov: NCT00520494 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
May 2013
Primary outcome: Primary: Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 — 0.944 proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vivaglobin (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 |
0.944 | — |
| SECONDARY Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19 |
0.944 | — |
| SECONDARY Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26 |
1.000 | — |
| SECONDARY IgG Increase (Change From Baseline) on Day 12 |
3.941 | — |
| SECONDARY Overall Rate of Infections |
2.785 | — |
| SECONDARY Total Serum IgG Trough Levels on Day 12 |
7.466 | — |
| SECONDARY Total Serum IgG Trough Levels at Week 25 |
8.039 | — |
| SECONDARY Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 |
3.182; 1.399; 0.743 | — |
| SECONDARY Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 |
3.638; 1.623; 0.879 | — |
| SECONDARY Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12 |
1.023; 18.588 | — |
| SECONDARY Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25 |
1.671; 26.985 | — |
| SECONDARY Use of Antibiotics for Infection Prophylaxis and Treatment |
1; 8 | — |
| SECONDARY Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) |
75.50; 70.63; 65.60; 56.40; 54.40; 80.00 | — |
| SECONDARY Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) |
82.50; 97.91; 100.00; 95.84; 82.50; 74.06 | — |
| SECONDARY Number of Patients With Adverse Events (AEs) by Severity and Relatedness |
14; 14; 5; 2; 14; 3 | — |
| SECONDARY Rate of AEs by Severity and Relatedness |
0.305; 0.263; 0.034; 0.007; 0.200; 0.013 | — |
| SECONDARY Number of Patients With Local Reactions by Severity and Relatedness |
6; 6; 0; 0; 1; 0 | — |
| SECONDARY Rate of Local Reactions by Severity and Relatedness |
0.076; 0.076; 0.000; 0.000; 0.004; 0.000 | — |
| SECONDARY Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters |
— | — |
| SECONDARY Number of Patients With Clinically Relevant Changes in Vital Signs |
— | — |
Summary
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.
Eligibility Criteria
Key Inclusion Criteria
- Written informed consent, age-adapted
- Male or female aged 1 to 70 years
- Diagnosis of primary humoral immunodeficiency
- No prior immunoglobulin substitution therapy
- IgG level of <5 g/L at screening
- Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening
Key Exclusion Criteria
- Evidence of serious infection between screening and first treatment
- Bleeding disorders that require medical treatments
- Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
- Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
Data sourced from ClinicalTrials.gov (NCT00520494). 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.