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

• Conditions: Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.; MedDRA version: 7.0Level: LLTClassification code 10021245

• Registration Number: EUCTR2005-003552-35-AT
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-16
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

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
F.1.3.1 Number of subjects for this age range

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.
- History of, or suspected drug abuse.
- Pregnant and nursing women.
- Unable or unwilling to comply with the study protocol.
- Participating in another clinical study currently or during the 3 months before study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to investigate the efficacy of Octagam® 10% in correcting the platelet count.;Secondary Objective: The secondary objective of the study is to investigate the safety of Octagam® 10%.;Primary end point(s): The primary endpoint is an increase in platelet count to at least 50.000/µL within 7 days after treatment.