Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

Phase 3

Completed

Conditions: Immune Thrombocytopenic Purpura

Interventions: Drug: Octagam 10%

Registration Number: NCT00426270

Lead Sponsor: Octapharma

Brief Summary: 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%.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 116

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Octagam 10% 1 g/kg/day	Octagam 10%	Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Clinical Response	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.

Secondary Outcome Measures

Name	Time	Method
Time to Achieve a Clinical Response	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.
Duration of the Clinical Response	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.
Maximum Platelet Count	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.
Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7	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).