Immune Thrombocytopenic Purpura Clinical Trial
Official title:
Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
Status | Completed |
Enrollment | 116 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Key Inclusion Criteria: - Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria. - Platelet count = 20 x 10^9/L. Key Exclusion Criteria: - Chronic refractory ITP patients. - Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia. - Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days before enrollment. - Administration of thrombocyte concentrates within 72 hours before baseline. - Experimental treatment (eg, rituximab) within 3 months before enrollment. - Prophylactic preoperative treatment for elective splenectomy. - Severe liver or kidney disease. - Pregnant or nursing female. - History of hypersensitivity to blood or plasma derived products. - Emergency operation. - Live viral vaccination within the last month prior to study entry. - Known IgA deficiency and antibodies against IgA. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Contact Octapharma for information | Vienna |
Lead Sponsor | Collaborator |
---|---|
Octapharma |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With a Clinical Response | A clinical response is defined as an increase in platelet count to = 50*10^9/L on any day from Day 2 to Day 7. | Day 2 to Day 7 | No |
Secondary | Time to Achieve a Clinical Response | A clinical response is defined as an increase in platelet count to = 50*10^9/L on any day from Day 2 to Day 7. | Day 2 to Day 7 | No |
Secondary | Maximum Platelet Count | Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported. | Day 2 to the end of the study (Day 63) | No |
Secondary | Duration of the Clinical Response | The duration of the clinical response was the number of days that the platelet count remained = 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was = 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21. | Day 2 to the end of the study (Day 63) | No |
Secondary | Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7 | The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [= 100 total] and/or = 5 small bruises [= 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention). | Day 7 | No |
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