E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Thrombocytopenic Purpura in adults actively bleeding or at high risk of bleeding |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021245 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of Octagam(R) 10% in correcting the platelet count. |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety of Octagam(R) 10%. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is an increase in platelet count to >= 50 x 10exp9/L within 7 days after treatment.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the last visit of the last patient undergoing the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |