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:
Octapharma
ClinicalTrials.gov Identifier:
NCT00426270
First received: January 22, 2007
Last updated: December 5, 2008
Last verified: December 2008

January 22, 2007
December 5, 2008
January 2006
September 2008   (final data collection date for primary outcome measure)
Increase in platelet count to more 50 x 10 to the 9th /L within 7 days after treatment [ Time Frame: 7 days after treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00426270 on ClinicalTrials.gov Archive Site
  • time to reach an increase in platelet count to more than 50 x 10 to the 9th / L [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • maximum platelet level [ Time Frame: 63 days ] [ Designated as safety issue: No ]
  • duration of platelet response [ Time Frame: 63 days ] [ Designated as safety issue: No ]
  • assessment of the severity of hemorrhages [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • tolerability [ Time Frame: 63 days ] [ Designated as safety issue: Yes ]
  • adverse event monitoring [ Time Frame: 63 days ] [ Designated as safety issue: Yes ]
  • assessment of viral safety [ Time Frame: 63 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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 double virus inactivated human normal immunoglobulin(IGIV) solution of intravenous administration. Octagam 5% is currently registered in about 60 countries. This study will evaluate 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 is to investigate the efficacy of Octagam® 10% in correcting the platelet count.The blood count as well as laboratory chemistry will be checked repeatedly up to day 21.

The secondary objective of the study is to investigate the safety of Octagam® 10%. Safety will be assessed by monitoring of vital signs, the evaluation of adverse event (AE) recordings and laboratory parameters, and by viral safety testing.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Thrombocytopenic Purpura
Drug: Octagam 10%
1g/kg/day of Octagam 10% will be infused ove 2 consecutive days
Not Provided
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
November 2008
September 2008   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Diagnosis of ITP according to standard criteria
  • Platelet count of less than or equal to 20 x 10 to the 9th/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(e.g.,Rituximab),within 3 months before enrollment
  • Prophylactic preoperative treatment for elective splenectomy
  • Severe liver or kidney disease
  • pregnant or nursing woman
  • History of hypersensitivity to blood or plasma derived products
  • Emergency operation
  • Live viral vaccination within the last month prior to study entry
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00426270
GAM10-02
Yes
Barbara Pyringer, Octapharma
Octapharma
Not Provided
Study Director: Wolfgang Frenzel, M.D. Octapharma
Octapharma
December 2008

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