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

• ClinicalTrials.gov Identifier: NCT00426270
• Recruitment Status: Completed
• First Posted: January 24, 2007
• Results First Posted: May 8, 2014
• Last Update Posted: August 1, 2014
• Sponsor: Octapharma
• Information provided by (Responsible Party): Octapharma

Study Description

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%.

Condition or disease	Intervention/treatment	Phase
Immune Thrombocytopenic Purpura	Drug: Octagam 10%	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
• Study Start Date: June 2006
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With a Clinical Response [ Time Frame: Day 2 to Day 7 ]
   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 :

1. Time to Achieve a Clinical Response [ Time Frame: Day 2 to Day 7 ]
   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.
2. Maximum Platelet Count [ Time Frame: Day 2 to the end of the study (Day 63) ]
   Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.
3. Duration of the Clinical Response [ Time Frame: Day 2 to the end of the study (Day 63) ]
   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.
4. Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7 [ Time Frame: Day 7 ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Austria

Contact Octapharma for information

Vienna, Austria

Sponsors and Collaborators

Octapharma

Investigators

• Study Director: Wolfgang Frenzel, MD; Octapharma

More Information

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

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. doi: 10.1179/102453310X12719010991867.

• Responsible Party: Octapharma
• ClinicalTrials.gov Identifier: NCT00426270
• Other Study ID Numbers: GAM10-02
• First Posted: January 24, 2007
• Results First Posted: May 8, 2014
• Last Update Posted: August 1, 2014
• Last Verified: July 2014

Additional relevant MeSH terms:

Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Blood Coagulation Disorders; Hematologic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Immune System Diseases; Hemorrhagic Disorders; Autoimmune Diseases; Immunoglobulins; Immunologic Factors; Physiological Effects of Drugs