Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
2 other identifiers
interventional
58
6 countries
17
Brief Summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10\^9/L.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2004
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedResults Posted
Study results publicly available
November 23, 2011
CompletedNovember 23, 2011
October 1, 2011
September 12, 2005
August 22, 2011
October 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Platelet Response
The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10\^9/L to ≥ 50 x 10\^9/L within the specified time frame.
7 days
Secondary Outcomes (8)
Regression of Hemorrhage (Skin)
up to 29 days
Regression of Hemorrhage (Oral Cavity)
29 days
Regression of Hemorrhage (Genitourinary Tract)
29 days
Regression of Hemorrhage (Nose)
29 days
Regression of Hemorrhage (Internal)
29 days
- +3 more secondary outcomes
Study Arms (1)
IgPro10
EXPERIMENTALInterventions
A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic ITP defined by: Failure to find other causes of thrombocytopenia; Platelet count ≤ 150 x 10\^9/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
- Platelet counts ≤ 20 x 10\^9/L
You may not qualify if:
- Planned splenectomy throughout the study period
- Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening
- Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening
- Treatment with intravenous steroids within 10 days prior to screening
- Change of oral steroid treatment within 15 days prior to screening
- Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy
- Abnormal results in the following laboratory parameters: Hemoglobin \< 10 g/dL; Total bilirubin \> 1.5 x upper normal limit; ALAT \> 2.5 x upper normal limit; ASAT \> 2.5 x upper normal limit; Creatinine \> 1.5 x upper normal limit; Urea \> 1.5 x upper normal limit
- Positive direct Coombs test
- Patients with one of the following concomitant diseases Clinical active SLE Known or suspected HIV infection Acute hepatitis Clinically active chronic hepatitis Lymphoproliferative disease Heart failure Grade III or IV according to the New York Heart Association classification
- Any other concomitant disease that has influence on the clotting system (i.e. hemophilia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (17)
Study Site
Berlin, Germany
Study Site
Rome, Italy
Study Site
Bialystok, Poland
Study Site
Gdansk, Poland
Study Site
Lodz, Poland
Study Site
Poznan, Poland
Study Site
Warsaw, Poland
Study Site
Wroclaw, Poland
Study Site
Moscow, Russia
Study Site (19)
Saint Petersburg, Russia
Study Site (20)
Saint Petersburg, Russia
Study Site (21)
Saint Petersburg, Russia
Study Site
Dnipropetrovsk, Ukraine
Study Site (02)
Kyiv, Ukraine
Study Site (03)
Kyiv, Ukraine
Study Site
Lviv, Ukraine
Study Site
Taunton, United Kingdom
Related Publications (1)
Robak T, Salama A, Kovaleva L, Vyhovska Y, Davies SV, Mazzucconi MG, Zenker O, Kiessling P; International Privigen in ITP Study Group. Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009 Aug;14(4):227-36. doi: 10.1179/102453309X439773.
PMID: 19635187RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure Manager
- Organization
- CSL Behring
Study Officials
- STUDY DIRECTOR
Othmar Zenker, MD
CSL Behring
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
December 1, 2004
Study Completion
February 1, 2006
Last Updated
November 23, 2011
Results First Posted
November 23, 2011
Record last verified: 2011-10