cystic fibrosis MedDRA version: 12.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
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 milli
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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;Primary end point(s): Reperfusion injury of human lung transplantation. | — |
Countries
Italy
Outcome results
None listed