Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A

Octapharma AG0 sites116 target enrollmentJanuary 16, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
Sponsor: Octapharma AG
Enrollment: 116
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

January 16, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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

•\- 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.