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: July 28, 2014
Last verified: July 2014
  Purpose

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%.


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

Study Type: Interventional
Study Design: 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:


Further study details as provided by Octapharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 116
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octagam 10% 1 g/kg/day
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
Drug: Octagam 10%
Octagam 10% was supplied as a ready-to-use solution in glass bottles.
Other Name: Human normal immunoglobulin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, MD Octapharma
  More Information

No publications provided by Octapharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00426270     History of Changes
Other Study ID Numbers: GAM10-02
Study First Received: January 22, 2007
Results First Received: April 7, 2014
Last Updated: July 28, 2014
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
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014