Back to resultsClinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Primary Purpose
Immune Thrombocytopenic Purpura
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Octagam 10%
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenic Purpura
Eligibility 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.
Sites / Locations
- Contact Octapharma for information
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Octagam 10% 1 g/kg/day
Arm Description
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
Outcomes
Primary Outcome Measures
Percentage of Participants With a Clinical Response
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
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
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00426270
Brief Title
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Official Title
Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Octapharma
4. Oversight
Data Monitoring Committee
Yes
5. 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%.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Octagam 10% 1 g/kg/day
Arm Type
Experimental
Arm Description
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
Intervention Type
Drug
Intervention Name(s)
Octagam 10%
Other Intervention Name(s)
Human normal immunoglobulin
Intervention Description
Octagam 10% was supplied as a ready-to-use solution in glass bottles.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Clinical Response
Description
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.
Time Frame
Day 2 to Day 7
Secondary Outcome Measure Information:
Title
Time to Achieve a Clinical Response
Description
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.
Time Frame
Day 2 to Day 7
Title
Maximum Platelet Count
Description
Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.
Time Frame
Day 2 to the end of the study (Day 63)
Title
Duration of the Clinical Response
Description
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.
Time Frame
Day 2 to the end of the study (Day 63)
Title
Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7
Description
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).
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Frenzel, MD
Organizational Affiliation
Octapharma
Official's Role
Study Director
Facility Information:
Facility Name
Contact Octapharma for information
City
Vienna
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
20863431
Citation
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(R) 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9. doi: 10.1179/102453310X12719010991867.
Results Reference
derived
Learn more about this trial
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
We'll reach out to this number within 24 hrs