E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with high-grade gliomas (world health organisation [WHO] grade III or IV) in the first relapse after first-line therapy including chemotherapy with or without nitrososurea, with a life expectancy of at least 6 months and undergoing active treatment with chemotherapy |
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MedDRA Classification |
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 determine the number of infective episodes in patients with high grade gliomas during treatment with 10% intravenous immunoglobulin (Kiovig) compared with placebo (normal saline). |
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E.2.2 | Secondary objectives of the trial |
To determine the following during treatment with Kiovig compared with placebo:
• number of patients with infective episodes • number of days on antibiotics • number of days with fever (body temperature (T) > 38.5°C) • number of infective deaths • number of hospitalisations • number of days in hospital • time to progression • Compare serum immunoglobulin G (IgG), IgA, and IgM levels • Assess the quality of life (QoL) • Karnofsky performance scale assessment and mini mental state examination (MMSE) • Assess the total costs (socioeconomic evaluation) • Evaluate reported adverse events (AEs), changes in vital signs, laboratory tests, and physical examination • Evaluate tumour progression |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female patients ≥ 18 years old 2. Patients with histologically confirmed high-grade gliomas (WHO Grade III or IV) in the first relapse 3. Patients undergoing first-line therapy containing a nitrosourea or non-nitrosourea based chemotherapy regimen 4. Life expectancy of at least 6 months (defined by the criteria: absence of midline shift and clinical brain pressure signs) 5. Active treatment with chemotherapy 6. Willing and able to give written informed consent 7. Female patients of child-bearing age must take double-barrier precautions to avoid pregnancy. Allowed double barrier methods are: hormonal agents (“Pille”) plus condom, or uterine pessar plus condom.
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E.4 | Principal exclusion criteria |
1. Participation in another clinical trial 2. Did not receive chemotherapy during first-line treatment 3. Severe infection requiring medical treatment at the time of study inclusion 4. IgA below normal 5. Hypersensitivity to the active ingredient or to the excipient of the Kiovig product. 6. Pregnancy 7. Suspected non-adherence to study procedures and follow up
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study will be the number of infective episodes in patients with high grade glioma during treatment with Kiovig compared with placebo. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |