Clinical trial NCT00168038: Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
Official title: An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenic Purpura
Keywords: Chronic Immune Thrombocytopenic Purpura
Chronic Idiopathic Thrombocytopenic Purpura
Werlhofs Disease
Autoimmune Thrombocytopenia
Immunglobulin Intravenous
Chronic ITP
Platelet count
Thrombocytopenia
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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)

Primary outcomes:
measure: Platelet Response
timeFrame: 7 days
Secondary outcomes:
measure: Regression of Hemorrhage (Skin)
timeFrame: up to 29 days
measure: Regression of Hemorrhage (Oral Cavity)
timeFrame: 29 days
measure: Regression of Hemorrhage (Genitourinary Tract)
timeFrame: 29 days
measure: Regression of Hemorrhage (Nose)
timeFrame: 29 days
measure: Regression of Hemorrhage (Internal)
timeFrame: 29 days
measure: Time to Platelet Response
timeFrame: 29 days
measure: Duration of Platelet Response
timeFrame: up to 29 days
measure: Maximum Platelet Level
timeFrame: 29 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Study Site
city: Rome
country: Italy
facility: Study Site
city: Bialystok
country: Poland
facility: Study Site
city: Gdansk
country: Poland
facility: Study Site
city: Lodz
country: Poland
facility: Study Site
city: Poznan
country: Poland
facility: Study Site
city: Warsaw
country: Poland
facility: Study Site
city: Wroclaw
country: Poland
facility: Study Site
city: Moscow
country: Russian Federation
facility: Study Site
city: St. Petersburg
country: Russian Federation
facility: Study Site (19)
city: St. Petersburg
country: Russian Federation
facility: Study Site (20)
city: St. Petersburg
country: Russian Federation
facility: Study Site (21)
city: Dnipropetrovsk
country: Ukraine
facility: Study Site
city: Kyiv
country: Ukraine
facility: Study Site (02)
city: Kyiv
country: Ukraine
facility: Study Site (03)
city: Lviv
country: Ukraine
facility: Study Site
city: Taunton
country: United Kingdom
facility: Study Site
Study officials:
affiliation: CSL Behring
name: Othmar Zenker, MD
role: STUDY_DIRECTOR
References:
citation: 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.