Trials / Completed
CompletedNCT01287689
Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study
An Open, Uncontrolled, Non-interventional Observational Cohort Outcome Study of Immunoglobulins in 3 Indications: Primary and Secondary Immunodeficiencies and Neurological Auto-immune Diseases
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 685 (actual)
- Sponsor
- Technische Universität Dresden · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This non-interventional, epidemiological study assesses long-term outcomes in subjects receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen prescribed by the treating physician, under routine clinical conditions in Germany. Long-term outcome data are collected on patient characteristics in the various indications, drug utilization of intravenous and subcutaneous IgG (e.g. treatment and dosing patterns), effectiveness (i.e. number of infections), tolerability, health related quality of life, and economic variables (number of hospitalizations, sick-leave days etc.) with the possibility to estimate direct costs.
Detailed description
In view of the broad range of indications in immunodeficiency and immunomodulation, it is of interest to document the use of IgG under the conditions of everyday practice and to analyze the endpoints (outcomes). A prospective cohort study such as this is an important evidence source for such rare diseases as those mentioned above. The aim of this outcome study is to fill the gap of the lack of long-term data in these rare diseases treated with IgG.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Immunoglobulin G (IgG) | Not applicable. All interventions are at the discretion of the investigator. All marketed IgG formulations can be documented. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2016-12-31
- Completion
- 2016-12-31
- First posted
- 2011-02-01
- Last updated
- 2017-08-01
Locations
7 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01287689. Inclusion in this directory is not an endorsement.