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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00426270
First received: January 22, 2007
Last updated: April 7, 2014
Last verified: April 2014

January 22, 2007
April 7, 2014
June 2006
September 2008   (final data collection date for primary outcome measure)
Percentage of Participants With a Clinical Response [ Time Frame: Day 2 to Day 7 ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00426270 on ClinicalTrials.gov Archive Site
  • Time to Achieve a Clinical Response [ Time Frame: Day 2 to Day 7 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
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Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
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%.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Immune Thrombocytopenic Purpura
Drug: Octagam 10%
Octagam 10% was supplied as a ready-to-use solution in glass bottles.
Other Name: Human normal immunoglobulin
Experimental: Octagam 10% 1 g/kg/day
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
Intervention: Drug: Octagam 10%
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® 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00426270
GAM10-02
Yes
Octapharma
Octapharma
Not Provided
Study Director: Wolfgang Frenzel, MD Octapharma
Octapharma
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP