D80 D69.3
Conditions
Interventions
Group 1: Flebogamma DIF 100 mg/ml in routine use
Group 2: Flebogamma DIF 50 mg/ml in routine use
Sponsors
Instituto Grifols, S.A.
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male or female aged 2 years or more 2.The subject is treated with Flebogamma DIF100 mg/ml or Flebogamma DIF50 mg/ml according to the prescribing physician and the SPC. 3.The subject freely gives written informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject is known to have history of intolerance to any Flebogamma DIFcontaining substances such as sorbitol (e.g. intolerance to fructose). 2. The subject is known to have history of anaphylactic reaction(s) to blood or blood components. 3. Has been diagnosed with IgA deficiency and has antibodies anti-IgA. 4. The subject is participating in another clinical study involving an investigational treatment, or participated within the past 4 weeks. 5. The subject is unlikely to adhere to the protocol requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this post-authorisation safety study is to assess the tolerability of Flebogamma DIF100 mg/ml in the clinical practice under routine conditions comparing the rate of infusions associated with potentially related adverse events between both strengths. Observation period up to 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall treatment outcome for each indication such as rate of infections per patient and period of treatment (replacement therapy), platelet count and bleeding regression (in ITP). Observation period up to 6 months. | — |
Countries
Germany, Spain, United Kingdom
Contacts
Public ContactBettina Dreger
Grifols Deutschland GmbH
Outcome results
None listed