Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
Public ClinicalTrials.gov record NCT02810444. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Study identification
- NCT ID
- NCT02810444
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Biotest
- Industry
- Enrollment
- 81 participants
Conditions and interventions
Conditions
Interventions
- IgG Next Generation (BT595) Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 3, 2016
- Primary completion
- Mar 31, 2020
- Completion
- Mar 31, 2020
- Last update posted
- Jul 19, 2023
2016 – 2020
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational site # 0104 | Birmingham | Alabama | 35294 | — |
| Investigational site # 0116 | Los Angeles | California | 90027 | — |
| Investigational site # 0103 | Centennial | Colorado | 80112 | — |
| Investigational site # 0114 | Thornton | Colorado | 80233 | — |
| Investigational site # 0111 | Chicago | Illinois | 60612 | — |
| Investigational site # 0106 | South Bend | Indiana | 46617 | — |
| Investigational site # 0105 | Toledo | Ohio | 43617 | — |
| Investigational site #0115 | Memphis | Tennessee | 38103-2800 | — |
| Investigational Site # 0102 | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02810444, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2023 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02810444 live on ClinicalTrials.gov.