Clinical trial NCT00426270: Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Official title: Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenic Purpura
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2007-01-24
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With a Clinical Response
timeFrame: Day 2 to Day 7
Secondary outcomes:
measure: Time to Achieve a Clinical Response
timeFrame: Day 2 to Day 7
measure: Maximum Platelet Count
timeFrame: Day 2 to the end of the study (Day 63)
measure: Duration of the Clinical Response
timeFrame: Day 2 to the end of the study (Day 63)
measure: Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Contact Octapharma for information
Study officials:
affiliation: Octapharma
name: Wolfgang Frenzel, MD
role: STUDY_DIRECTOR
References:
citation: Robak T, Mainau C, Pyringer B, Chojnowski K, Warzocha K, Dmoszynska A, Straub J, Imbach P. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam(R) 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9. doi: 10.1179/102453310X12719010991867.