Post-Authorisation Surveillance Safety study with Flebogamma DIF100 mg/ml and Flebogamma DIF50 mg/ml

• Conditions: D80; D69.3; Immunodeficiency with predominantly antibody defects; Idiopathic thrombocytopenic purpura

• Registration Number: DRKS00003877
• Lead Sponsor: Instituto Grifols, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-06
• Study Completion: 2014-10-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 67

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.