Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10

NCT ID: NCT00168038

Last Updated: 2011-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2006-02-28

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.

Conditions

Immune Thrombocytopenic Purpura

Keywords

Chronic Immune Thrombocytopenic Purpura; Chronic Idiopathic Thrombocytopenic Purpura; Werlhofs Disease; Autoimmune Thrombocytopenia; Immunglobulin Intravenous; Chronic ITP; Platelet count; Thrombocytopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IgPro10

Group Type: EXPERIMENTAL

Immunoglobulin Intravenous (Human)

Intervention Type: BIOLOGICAL

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.

Interventions

Immunoglobulin Intravenous (Human)

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Privigen; IgPro10

Eligibility Criteria

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

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Othmar Zenker, MD

Role: STUDY_DIRECTOR

CSL Behring

Locations

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

Countries

Switzerland; Germany; Italy; Poland; Russia; Ukraine; United Kingdom

References

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.

Reference Type: RESULT

PMID: 19635187 (View on PubMed)

Other Identifiers

2004-000537-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZLB03_003CR

Identifier Type: -

Identifier Source: org_study_id