Main
|
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. |
Register:
|
EUCTR |
Last refreshed on:
|
27 January 2014 |
Main ID: |
EUCTR2009-013340-36-IT |
Date of registration:
|
31/12/2009 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND
|
Scientific title:
|
PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND |
Date of first enrolment:
|
25/01/2010 |
Target sample size:
|
|
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013340-36 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
Phase:
|
|
|
Countries of recruitment
|
Italy
| | | | | | | |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: - Adults, male or female patients with cystic fibrosis - No contraindications to lung transplantation - Life expectancy of 2 years or less (estimated from various clinical and physiological measurements, such as forced expiratory volume in 1 second (FEV1) of less than 30%, resting hypoxia PaO2 <55 mmHg, hypercapnia) - Poor quality of life - Bilateral lung transplantation or occasionally single lung (patients with previous pneumonectomy) - Written informed consent 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: - Severe irreversible damage to other organs such liver who require liver and lung transplant - Ventilator-dependent respiratory failure - Hepatitis B antigen positivity, or hepatitis C seropositivity with evidence of ongoing disease - Active mycobacterium tuberculosis infection - HIV infection - Malignancy - Major psychiatric illness - Adult patients not fully committed to the procedure - Hypersensitivity to non-steroidal anti-inflammatory drugs
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
cystic fibrosis MedDRA version: 12.1
Level: LLT
Classification code 10011762
Term: Cystic fibrosis
|
Intervention(s)
|
Product Name: reparixin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Reparixin CAS Number: 266359-83-5 Current Sponsor code: DF 1681Y Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 33- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
|
Primary Outcome(s)
|
Secondary Objective: 1. To limit episodes of pulmonary infections related to prolonged mechanical ventilation due to ischemia/reperfusion injury 2. To reduce episodes of acute rejection by limiting ischemia-reperfusion-induced lung injury
|
Main Objective: To investigate the role of IL-8 in the reperfusion injury of human lung transplantation for cystic fibrosis by selective pharmacologic inhibition of IL-8 activity.
|
Primary end point(s): Reperfusion injury of human lung transplantation.
|
Source(s) of Monetary Support
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|