Trials / Completed
CompletedNCT02810444
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Biotest · Industry
- Sex
- All
- Age
- 2 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IgG Next Generation (BT595) |
Timeline
- Start date
- 2016-10-04
- Primary completion
- 2020-04-01
- Completion
- 2020-04-01
- First posted
- 2016-06-23
- Last updated
- 2023-07-20
- Results posted
- 2023-07-12
Locations
19 sites across 5 countries: United States, Germany, Hungary, Russia, Spain
Source: ClinicalTrials.gov record NCT02810444. Inclusion in this directory is not an endorsement.