Primary Immune Thrombocytopenia (ITP). Haematological Disorders Other primary thrombocytopenia
Conditions
Interventions
Administration of intravenous immunoglobulin (IVIG). One treatment arm: treatment with Octagam 10% at two consecutive days at a dosage of 1 g/kg/day.
Laboratory assessments.
Sponsors
Octapharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of >=18 years and <=65 years 2. Confirmed diagnosis of chronic primary ITP (threshold PC less than 100x10^9/L) of at least 12 months duration 3. Platelet count of <30x10^9/L with or without bleeding manifestations
Exclusion criteria
Exclusion criteria: 1. Thrombocytopenia secondary to other diseases (such as AIDS or SLE) or drug-related thrombocytopenia 2. Administration of IVIG, anti-D or thrombopoietin receptor agonists or other platelet enhancing drugs (including immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrolment 3. Unresponsive to previous treatment with IVIG or anti-D immunoglobulin 4. Severe liver or kidney disease (ALAT 3x > upper limit of normal, creatinine >120 µmol/L) 5. Patients with risk factors for TEEs in whom the risks outweigh the potential benefit of Octagam treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Platelet count and the increase in platelets to ? and the maintenance of ? specific thresholds 2. Number and percentage of patients with response (R), complete response (CR), no response (NR) and loss of response as well as time to response and duration of response will be presented descriptively to facilitate the comparison of the study results to data from the literature | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety of Octagam 10% | — |
Countries
Bulgaria, Czech Republic, Germany, Poland, Romania
Outcome results
None listed