Clinical study to evaluate the efficacy and safety of Octagam(R) 10% in Idiopathic Thrombocytopenic Purpura in adults - NA

• Conditions: Idiopathic Thrombocytopenic Purpura in adults actively bleeding or at high risk of bleeding; MedDRA version: 7.0Level: LLTClassification code 10021245

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Age >= 18 years
- Diagnosis of ITP according tostandard criteria i.e. isolated thrombocytopenia with an otherwise normal peripheralblood smear (bone marrow examination optional), and absence of other causes of thrombocytopenia
- Platelet count <= 20x 10exp9/L with or without bleedeing manifestations
- Freely given 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 reliability 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 immunoglobulin and anti-D) or require unnaceptably high doses of corticosteroids to maintain a safe platelet count
- Thrombocytopenia secondayr to other diseases (such as AIDS) or drug related thrombocytopenia
- Administration of IGIV, anti-D ot 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 and except for long-term azathioprine therapy in patients with chronic ITP when the dose has been stable during the preceding 3 months and no dosage increase is planned during the study.
- Administration of thrombocyte concentrates within 72 hours before baseline.
- 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 (ALAT 5x > normal value, creatinine > 120 micromol/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 orwilling 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: To investigate the efficacy of Octagam(R) 10% in correcting the platelet count.;Secondary Objective: To investigate the safety of Octagam(R) 10%.;Primary end point(s): Primary endpoint is an increase in platelet count to >= 50 x 10exp9/L within 7 days after treatment.<br>