Trials / Completed
CompletedNCT01888484
Study of Octanorm Subcutaneous IG in Patients With PID
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 2 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | octanorm 16.5% | octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2020-06-09
- Completion
- 2020-06-09
- First posted
- 2013-06-27
- Last updated
- 2021-08-17
- Results posted
- 2021-08-17
Locations
24 sites across 7 countries: United States, Canada, Czechia, Hungary, Poland, Russia, Slovakia
Source: ClinicalTrials.gov record NCT01888484. Inclusion in this directory is not an endorsement.