EUCTR2005-003552-35-DE
Active, not recruiting
Not Applicable
Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Octapharma AG
- Enrollment
- 116
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age of at least 18 years.
- •\- Diagnosis of ITP according to standard criteria i.e. isolated thrombocytopenia with an otherwise normal peripheral blood smear (bone marrow examination optional), and absence of other causes of thrombocytopenia.
- •\- Platelet count of 20\.000/µL or less with or without bleeding manifestations.
- •\- Freely given written informed consent from patient.
- •\- Women of reproductive age: negative result on a pregnancy test (HCG\-based assay) and will practice contraception using a method of proven reliabilty for the duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\- Chronic refractory ITP patients, defined as those who fail to respond to standard treatment (oral corticosteroids and intravenous immunglobulin and anti\-D) or require unacceptably high doses of corticosteroids to maintain a safe platelet count.
- •\- Thrombocytopenia secondary to other diseases (such as AIDS) or drug\-related thrombocytopenia.
- •\- Administration of IGIV, anti\-D or other platelet enhancing drugs within 30 days before enrollment, except for long\-term corticosteroid therapy in patients with chronic ITP when the dose has been stable during the preceding 30 days and no dosage increase is planned within 7 days after treatment.
- •\- Experimental treatment (eg Rituximab) within 3 months before enrollment.
- •\- Prophylactic preoperative treatment for elective splenectomy.
- •\- Live viral vaccination within the last month before study entry.
- •\- Emergency operation.
- •\- Severe liver or kidney disease (ALAT 5x \> normal value, creatinine \> 120 µmol/L).
- •\- History of hypersensitivity to blood or plasma derived products, or any component of the product, such as maltose.
- •\- Known IgA deficiency and antibodies against IgA.
Outcomes
Primary Outcomes
Not specified
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Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/AIdiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.MedDRA version: 7.0Level: LLTClassification code 10021245EUCTR2005-003552-35-ATOctapharma AG116