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Main
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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: |
EUCTR2010-022027-30-BE |
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Date of registration:
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02/09/2010 |
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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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A randomized placebo-controlled double blind study to prevent BOS - VIT001
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Scientific title:
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A randomized placebo-controlled double blind study to prevent BOS - VIT001 |
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Date of first enrolment:
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23/09/2010 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022027-30 |
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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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Belgium
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Stable LTx recipients at discharge after transplantation.
• Signed informed consent
• Adult (age at least 18 years old at moment of transplantation)
• Able to take oral medication
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Prolonged and/or complicated ICU-course after transplantation.
• Early (<30 days post-transplant) post-operative death
• Major suture problems (airway stenosis or stent)
• Retransplantation (lung)
• Previous transplantation (solid organ)
• Multi-organ transplantation (lung+ other solid organ)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux
MedDRA version: 12.1
Level: LLT
Classification code 10029888
Term: Obliterative bronchiolitis
MedDRA version: 12.1
Level: LLT
Classification code 10049202
Term: Bronchiolitis obliterans
MedDRA version: 12.1
Level: LLT
Classification code 10068805
Term: Follicular bronchiolitis
MedDRA version: 12.1
Level: LLT
Classification code 10019319
Term: Heart-lung transplant rejection
MedDRA version: 12.1
Level: LLT
Classification code 10025127
Term: Lung transplant
MedDRA version: 12.1
Level: LLT
Classification code 10050433
Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1
Level: LLT
Classification code 10050437
Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.1
Level: LLT
Classification code 10051604
Term: Lung transplant rejection
MedDRA version: 12.1
Level: LLT
Classification code 10056409
Term: Heart and lung transplant
MedDRA version: 12.1
Level: LLT
Classification code 10016547
Term: FEV
MedDRA version: 12.1
Level: LLT
Classification code 10016549
Term: FEV 1 abnormal
MedDRA version: 12.1
Level: LLT
Classification code 10016550
Term: FEV 1 decreased
MedDRA version: 12.1
Level: LLT
Classification code 10016553
Term: FEV 1 low
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Intervention(s)
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Trade Name: D-Cure
Product Name: D-cure
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 25000-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: • Prevalence of BOS (grade 1) at 2 and 3 year post-transplant
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Primary end point(s): Development of chronic rejection
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Secondary Objective: • BAL: cells (differential cell count, fibrocytes)
proteins (IL-17, IL-8, IL-6, LTD4),
microbiology
• Peripheral blood: CRP and fibrocytes
• CMV and non-CMV infection rates
• Acute rejection and lymphocytic bronchiolitis rates
• Reflux (clinical and biochemical approach)
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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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