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Clinical Trials/EUCTR2011-000263-27-BG
EUCTR2011-000263-27-BG
Active, not recruiting
Not Applicable

An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP

CSL Behring GmbH0 sites150 target enrollmentAugust 25, 2011
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ConditionsChronic immune thrombocytopenic purpura (ITP)MedDRA version: 16.0Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsPrivigen®

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic immune thrombocytopenic purpura (ITP)
Sponsor
CSL Behring GmbH
Enrollment
150
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 25, 2011
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of chronic ITP defined by:
  • •?\- Failure to find other causes of thrombocytopenia,
  • •?\- Platelet count of \= 150 x 109/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months;
  • •Age of 18 to 65 years;
  • •Platelet count of \= 30 x 109/L at screening;
  • •Written informed consent for study participation obtained before undergoing any study specific procedures.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 150

Exclusion Criteria

  • •Planned splenectomy throughout the study period;
  • •Treatment with IVIG or anti\-D immunoglobulin within 3 weeks prior to screening;
  • •Drugs that have any pharmacological effect on the blood clotting system within 3 weeks prior to screening
  • •(i.e., clotting factors, heparin, coumarin derivates, acetylsalicylic acid in high dose, and thrombopoietin receptor agonists \[e.g., eltrombopag and romiplostim]);
  • •Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. aseptic meningitis, recurrent severe headache, hypersensitivity, intravascular hemolysis);
  • •Known hyperprolinemia;
  • •IgA levels below the detection limit
  • •Abnormal results in the following laboratory parameters at screening:
  • •?\- Hemoglobin \< 11 g/dL,
  • •?\- Positive DAT,

Outcomes

Primary Outcomes

Not specified

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