Trials / Completed
CompletedNCT01108848
Patient Registry Study of Berinert® in Normal Clinical Practice
Patient Registry for Berinert®, a C1-Esterase Inhibitor
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 318 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years. The duration of individual patient participation will vary and is determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for Berinert® treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Berinert® (C1 Esterase Inhibitor) | Berinert® is marketed as a lyophilized concentrate available in a single-use vial to be reconstituted with sterile water before administration as described in the prescribing information. |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2010-04-22
- Last updated
- 2014-06-09
Locations
40 sites across 4 countries: United States, Denmark, Germany, Switzerland
Source: ClinicalTrials.gov record NCT01108848. Inclusion in this directory is not an endorsement.