Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0 Level: LLT Classification code 10021245
Conditions
Interventions
Product Name: Octagam® 10%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Immunoglobulin G
Current Sponsor code: GAM10
Concentration unit: % percent
Concentration type: equal
Co
Sponsors
Octapharma AG
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Czech Republic, France, Germany
Outcome results
None listed