Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults|
- Percentage of Participants With a Clinical Response [ Time Frame: Day 2 to Day 7 ]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.
- Time to Achieve a Clinical Response [ Time Frame: Day 2 to Day 7 ]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.
- Maximum Platelet Count [ Time Frame: Day 2 to the end of the study (Day 63) ]Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.
- Duration of the Clinical Response [ Time Frame: Day 2 to the end of the study (Day 63) ]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.
- Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7 [ Time Frame: 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).
|Study Start Date:||June 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: Octagam 10% 1 g/kg/day
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
Drug: Octagam 10%
Octagam 10% was supplied as a ready-to-use solution in glass bottles.
Other Name: Human normal immunoglobulin
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426270
|Contact Octapharma for information|
|Study Director:||Wolfgang Frenzel, MD||Octapharma|