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Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases
This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacokinetic (PK) characteristics of octanorm.
Details
| Lead sponsor | Octapharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 75 |
| Start date | 2014-03 |
| Completion | 2020-06-09 |
Conditions
- Primary Immune Deficiency Disorder
Interventions
- octanorm 16.5%
Primary outcomes
- Rate of SBI Per Person-year — Every 4 weeks until the final evaluation at week 65.
The primary efficacy outcome is the rate of SBI (Serious bacterial infections - defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess) per person-year on treatment. - AUC(t) at Steady-State Conditions — Measured at Week 28 before the start of the SC infusion, 10 minutes before the end of the infusion, and at 2 h, 1, 2, 3, 4 and 7 days after the end of the infusion. Calculated and averaged.
The primary endpoint with respect to the PK investigations is the area under the curve AUC(t) (i.e., AUC from time 0 (start of the infusion) to the end of the nominal dosing period, standardised to 1 week) at PKSC2 at steady-state conditions.
Countries
United States, Canada, Czechia, Hungary, Poland, Russia, Slovakia