Primary Immune Thrombocytopenia (ITP) Haematological Disorders Other primary thrombocytopenia
Conditions
Interventions
All patients will receive 1 g/kg/day NewGam by intravenous infusion for 2 consecutive days, for a total of 2 g/kg.
Sponsors
Octapharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of >=18 years years and <=65 years 2. Confirmed diagnosis of chronic primary ITP of at least 12 months duration (diagnosed with threshold platelet count less than 100x109/L) 3. Platelet count of <=20x10exp9/L with or without bleeding manifestations
Exclusion criteria
Exclusion criteria: 1. Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia. 2. Administration of intravenous immunoglobulin (IGIV), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment 3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin. 4. Severe liver or kidney disease (alanine aminotransferase [ALAT] 3x > upper limit of normal, creatinine >120 µmol/L). 5. Patients with risk factors for thromboembolic events in whom the risks outweigh the potential benefit of NewGam treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy measure is defined as an increase in platelets to atleast 50x109/L within 7 days after the first infusion, i.e. by study Day 8 (at least once prior to Day 9). | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional response rates will be calculated on basis of an alternative definition for response and for additionally defined criteria for complete response and loss of response. | — |
Countries
Bulgaria, Czech Republic, France, Germany, India, Poland, Romania, Russian Federation, Ukraine
Outcome results
None listed