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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00426270 |
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Date of registration:
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22/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
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Scientific title:
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Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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116 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00426270 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Contacts
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Name:
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Wolfgang Frenzel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Octapharma |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Immune Thrombocytopenic Purpura
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Intervention(s)
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Drug: Octagam 10%
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Primary Outcome(s)
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Percentage of Participants With a Clinical Response
[Time Frame: Day 2 to Day 7]
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Secondary Outcome(s)
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Duration of the Clinical Response
[Time Frame: Day 2 to the end of the study (Day 63)]
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Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7
[Time Frame: Day 7]
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Time to Achieve a Clinical Response
[Time Frame: Day 2 to Day 7]
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Maximum Platelet Count
[Time Frame: Day 2 to the end of the study (Day 63)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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