PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND

• Conditions: cystic fibrosis; MedDRA version: 12.1Level: LLTClassification code 10011762Term: Cystic fibrosis

• Registration Number: EUCTR2009-013340-36-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-31
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified