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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-005548-25-DE |
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Date of registration:
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19/11/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective, randomised (using minimisation), double-blind, placebo controlled study to evaluate the safety and efficacy of human normal immunoglobulin as a prophylactic agent against infections in patients with high grade gliomas
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Scientific title:
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Prospective, randomised (using minimisation), double-blind, placebo controlled study to evaluate the safety and efficacy of human normal immunoglobulin as a prophylactic agent against infections in patients with high grade gliomas |
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Date of first enrolment:
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28/07/2008 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005548-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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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.
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) no
F.1.3.1 Number of subjects for this age range
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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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Intervention(s)
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Trade Name: Kiovig
Product Name: Kiovig
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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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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Main Objective: 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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Secondary Objective: 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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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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