Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003877

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The objective of this non-interventional trialis is to assess the tolerability of Flebogamma DIF 100 mg/ml in comparison to Flebogamma DIF 50 mg/ml under routine conditions.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003877
  •   2012/06/06
  •   [---]*
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NIS173 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   D80 -  Immunodeficiency with predominantly antibody defects
  •   D69.3 -  Idiopathic thrombocytopenic purpura
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Flebogamma DIF 100 mg/ml in routine use
  •   Flebogamma DIF 50 mg/ml in routine use
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Spain
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • other 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/02/08
  •   70
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Instituto Grifols, S.A.
    • Polígono Levante. C/ Can Guasch 2
    • 08150  Parets del Vallès Barcelona
    • Spain
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0034-935710700
    •   0034-935710381
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Grifols Deutschland GmbH
    • Ms.  Dr.  Bettina  Dreger 
    • Colmarer Str. 22
    • 60528  Frankfurt
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Grifols Deutschland GmbH
    • Ms.  Dr.  Bettina  Dreger 
    • Colmarer Str. 22
    • 60528  Frankfurt
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Instituto Grifols, S.A.
    • Polígono Levante. C/ Can Guasch 2
    • 08150  Parets del Vallès Barcelona
    • Spain
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0034-935710700
    •   0034-935710381
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/10/15
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.