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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00168038
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: CSL Behring
• Public title: Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
• Scientific title: An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
• Date of first enrolment: December 2004
• Target sample size: 58
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00168038
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Germany, Italy, Poland, Russian Federation, Switzerland, Ukraine, United Kingdom

Contacts

• Name: Othmar Zenker, MD
• Affiliation: CSL Behring

Key inclusion & exclusion 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)



Age minimum: 12 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenic Purpura

Intervention(s)

Biological: Immunoglobulin Intravenous (Human)

Primary Outcome(s)

Platelet Response [Time Frame: 7 days]

Secondary Outcome(s)

Regression of Hemorrhage (Nose) [Time Frame: 29 days]

Regression of Hemorrhage (Oral Cavity) [Time Frame: 29 days]

Regression of Hemorrhage (Internal) [Time Frame: 29 days]

Regression of Hemorrhage (Genitourinary Tract) [Time Frame: 29 days]

Maximum Platelet Level [Time Frame: 29 days]

Regression of Hemorrhage (Skin) [Time Frame: up to 29 days]

Duration of Platelet Response [Time Frame: up to 29 days]

Time to Platelet Response [Time Frame: 29 days]

Secondary ID(s)

2004-000537-11

ZLB03_003CR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/11/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00168038