Phase 3
N=75
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Primary Immunodeficiency
Bottom Line
View on ClinicalTrials.gov: NCT02269163 ↗Enrolled (actual)
75
Serious AEs
8.5%
Results posted
Aug 2021
Primary outcome: Primary: Annual Rate of Occurrence of Serious Bacterial Infections (SBI) — 0; 0.01; 0; 0.03 Rate of events per subject per year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Immune Globulin Intravenous (Biological); Prometic's Immune Globulin Intravenous 10% (Biological)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Prometic Biotherapeutics, Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Rate of Occurrence of Serious Bacterial Infections (SBI) |
0; 0.01; 0; 0.03 | — |
| SECONDARY Trough Levels of IgG (Total) Prior to Each Prometic IGIV 10% Infusion |
1075.131; 1043.401; 1070.725; 988.752 | — |
Summary
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
Eligibility Criteria
Inclusion Criteria
- Subject is male or female between the ages of 2 and 80 years at Screening.
- Female subjects of childbearing potential must agree to employ adequate birth control measures, as determined by their IRB/IEC, for the duration of the study.
- The subject must have one of the following three diagnoses (isolated PIDD of other types will be excluded):
- Common variable immunodeficiency
- X-linked agammaglobulinemia
- Hyper-IgM syndrome and documented low IgG levels ( 2.5 times the upper limit of normal (ULN).
- Subject has serum creatinine >1.5 times the ULN or a severe chronic condition such as renal failure with proteinuria.
- Subject has anemia with a hemoglobin level ≤8 g/dL.
- Subject has severe neutropenia with neutrophil count ≤1000 per mmᴧ3 or has lymphopenia with <500 per/ mmᴧ3.
- Subject is taking prednisone at a dose ≥0.15 mg/kg/day and receiving other immunosuppressive drugs or chemotherapy.
- Subject has known atrial fibrillation requiring anticoagulant therapy; congestive heart failure (New York Heart Association Class III/IV); cardiomyopathy; or cardiac arrhythmia associated with thromboembolic events, unstable or advanced ischemic heart disease, or hyperviscosity.
- Subject has known decreased Protein C and/or Protein S levels.
- Subject is positive for antibodies to β2GPI and/or β2GPI DI at Screening.
- Female subject who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.
- A history of epilepsy or multiple episodes of migraine (defined as at least one episode within 6 months of enrolment) not completely controlled by medication, or any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study in the Investigator's opinion.
Data sourced from ClinicalTrials.gov (NCT02269163). 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.