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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.
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: IST. DI RICERCHE FARMACOLOG. M. NEGRI
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
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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.
Secondary Outcome(s)
Secondary ID(s)
RPT02
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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