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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
History of Changes
  Purpose

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%.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
 Drug: Octagam 10%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 116
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Octagam 10%
    1g/kg/day of Octagam 10% will be infused ove 2 consecutive days
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426270

Locations
Austria
Contact Octapharma for information
Vienna, Austria
Sponsors and Collaborators
Octapharma
Investigators
Study Director: Wolfgang Frenzel, M.D. Octapharma
  More Information

No publications provided by Octapharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Barbara Pyringer, Octapharma
ClinicalTrials.gov Identifier: NCT00426270     History of Changes
Other Study ID Numbers: GAM10-02
Study First Received: January 22, 2007
Last Updated: December 5, 2008
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Czech Republic: State Institute for Drug Control
Austria: Agency for Health and Food Safety
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
 Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013