Trials / Completed
CompletedNCT00806533
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,130 (actual)
- Sponsor
- B. Braun Melsungen AG · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%) | solution for intravenous infusion applied according to SmPC |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-12-11
- Last updated
- 2009-05-19
Locations
10 sites across 5 countries: Austria, Czechia, Germany, Italy, Netherlands
Source: ClinicalTrials.gov record NCT00806533. Inclusion in this directory is not an endorsement.