Clinical trial
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced…
NCT00161993 · Baxalta now part of Shire, Industry · Completed
Key facts
| NCT number | NCT00161993 |
|---|---|
| Title | Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia) |
| Official title | Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia |
| Lead sponsor | Baxalta now part of Shire, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Primary Immunodeficiency Diseases (PID), Agammaglobulinemia, Hypogammaglobulinemia |
| Intervention type | Drug |
| Interventions | Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution, Gammagard S/D (Solvent/Detergent) |
| Enrollment | 24 |
| Start date | Jun 13, 2002 |
| Primary completion | Sep 24, 2003 |
| Completion | Sep 24, 2003 |
| First posted | Sep 13, 2005 |
| Last update posted | Aug 24, 2021 |
| Countries | Finland, Sweden |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: