Adults 18 to 65, any sex, with Ischemia-Reperfusion Injury or Lung Transplantation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PaO2/FiO2 Ratio at ICU Admission (Time 0) and 24 HoursPrimary· At T0 (time of ICU admission) and 24 hours post-ICU admission
The PaO2/FiO2 ratio was calculated to assess the severity of hypoxemia, or low blood oxygen levels. A low PaO2/FiO2 value has been associated with increased mortality and hospital stay in patients admitted to the intensive care unit (ICU). It was calculated by dividing the partial pressure of oxygen in arterial blood (PaO2) by the fraction of inspired oxygen (FiO2). A normal P/F ratio was typically above 300, and a lower ratio indicates a greater severity of hypoxemia. As the Pa02/Fi02 ratio was dependent on altitude, data were corrected for altitude in the analyses of corrected data. The corr
ICU Admission (Time 0)
Group
Value
95% CI
Repertaxin (ITT)
346.3
± 125.5
Placebo (ITT)
337.9
± 143.0
24 Hours Post ICU Admission
Group
Value
95% CI
Repertaxin (ITT)
320.1
± 119.5
Placebo (ITT)
307.3
± 111.3
PaO2/FiO2 Ratio (ICU Admission Then 24 Hours up to Extubation or up to 72 Hours)Secondary· At ICU admission (T0), 24, 48 and 72 hours post-ICU admission
Time profile of oxygenation was a comparison of the sequential measurements of the ratios of arterial PaO2 to inspired oxygen fractions FiO2. Herein repeated measurements analysis of PaO2/FiO2 ratio corrected after ICU admission using a one-sided test excluding missing data.
ICU Admission (Time 0)
Group
Value
95% CI
Repertaxin (ITT)
346.3
± 125.5
Placebo (ITT)
337.9
± 143.0
24 Hours Post ICU Admission
Group
Value
95% CI
Repertaxin (ITT)
320.1
± 119.5
Placebo (ITT)
307.3
± 111.3
48 Hours Post ICU Admission
Group
Value
95% CI
Repertaxin (ITT)
266.1
± 117.3
Placebo (ITT)
279.2
± 151.8
72 Hours Post ICU Admission
Group
Value
95% CI
Repertaxin (ITT)
275.6
± 88.1
Placebo (ITT)
233.9
± 132.0
Number of Patients With Different Primary Graft Dysfunction (PGD) Scores (0-3, and Missing Data)Secondary· At ICU admission (T0), 24, 48 and 72 hours post-ICU admission
PGD after lung transplantation ranged from mild to severe depending on the level of hypoxaemia and lung injury post-transplant.
PGD score was calculated according to the scoring system below:
Grade 0 PaO2/FiO2 \>=300 mmHg; no radiographic infiltrates (RI); Grade 1 PaO2/FiO2 \>=300mmHg + RI consistent with pulmonary oedema; Grade 2 200 mmHg \<=PaO2/FiO2 \<=300 mm Hg + RI consistent with pulmonary oedema; Grade 3 PaO2/FiO2 \< 200 mm Hg + RI consistent with pulmonary oedema. The higher the score, the worse the outcome. Any patient with no infiltrate on chest X-rays was automatically Grade 0. If
ICU Admission (Time 0) - PGD Score Missing
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
1
ICU Admission (Time 0) - PGD Score 0
Group
Value
95% CI
Repertaxin (ITT)
28
Placebo (ITT)
33
ICU Admission (Time 0) - PGD Score 1
Group
Value
95% CI
Repertaxin (ITT)
9
Placebo (ITT)
8
ICU Admission (Time 0) - PGD Score 2
Group
Value
95% CI
Repertaxin (ITT)
6
Placebo (ITT)
4
ICU Admission (Time 0) - PGD Score 3
Group
Value
95% CI
Repertaxin (ITT)
3
Placebo (ITT)
9
24 Hours Post ICU Admission - PGD Score Missing
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
1
24 Hours Post ICU Admission - PGD Score 0
Group
Value
95% CI
Repertaxin (ITT)
22
Placebo (ITT)
30
24 Hours Post ICU Admission - PGD Score 1
Group
Value
95% CI
Repertaxin (ITT)
14
Placebo (ITT)
12
Time to Freedom From Mechanical VentilationSecondary· At 24, 48, 72 hours post ICU admission
Time to freedom from mechanical ventilation was defined as "time between admission to the ICU and the initial time of first extubation (breathing off mechanical ventilation without a tube) which was maintained for more than 24 hours". This number was measured in hours and was derived as (date/time of extubation-date/time of ICU admission)/3600. The longer the time, the worst the outcome.Time to freedom from mechanical ventilation, if greater than 1 month (720 hours), was censored to 720 hours. Patients re-transplanted were censored at the date/time of re-transplant. Herein differences in the t
24 Hours Post-ICU Admission
Group
Value
95% CI
Repertaxin (ITT)
0.5000
± 0.0737
Placebo (ITT)
0.4909
± 0.0674
48 Hours Post-ICU Admission
Group
Value
95% CI
Repertaxin (ITT)
0.6957
± 0.0678
Placebo (ITT)
0.7273
± 0.0601
72 Hours Post-ICU Admission
Group
Value
95% CI
Repertaxin (ITT)
0.7391
± 0.0647
Placebo (ITT)
0.8052
± 0.0541
Probability of Death During Intensive Care Unit (ICU) Stay at Different TimepointsSecondary· At 24, 48, 72 hours post ICU admission
The duration of ICU stay, in term of hours, at different timepoints, in both placebo and repertaxin groups, was measured. The longer the ICU stay, the worse the outcome. mean event probability" (death) and its standard error (SE) at each timepoint.
At 24 h hours post ICU admission
Group
Value
95% CI
Repertaxin (ITT)
0.0000
± 0.0000
Placebo (ITT)
0.0364
± 0.0252
At 48 h hours post ICU admission
Group
Value
95% CI
Repertaxin (ITT)
0.3261
± 0.0691
Placebo (ITT)
0.2909
± 0.0612
At 72 h hours post ICU admission
Group
Value
95% CI
Repertaxin (ITT)
0.4783
± 0.0737
Placebo (ITT)
0.4962
± 0.0679
Number of Patients Dead Within 30 Days Post-transplantSecondary· Up to 30 days post-transplant
Mortality, defined as any death occurring in the first 30 days post-transplant, regardless of hospital discharge.
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
1
Pulmonary Function Tests (FEV1=Forced Expiratory Volume in One Second and FVC=Forced Vital Capacity) at Month 1, 6 and 12 Post-transplant Evaluated According to Estenne et al.(2002).Secondary· At months 1, 6 and 12 post-transplant
Forced expiratory volume in 1 second (FEV1) measured the amount/ volume, exhaled by a patient in the first second of the expiration after a full inspiration. Average values in healthy patients aged 20-60 range from 4.5 to 3.5 liters in males and from 3.25 to 2.5 liters in females. Forced vital capacity (FVC) was the volume of air that a patient could exhale with a maximal forced expiration effort after a deep inhaling, simply put, how much air a patient could breathe out by blowing as fast as possible. Average values in healthy patients aged 20-60 range from 5.5 to 4.75 liters in males and fro
FEV1 - Month 1 post transplant
Group
Value
95% CI
Repertaxin (ITT)
2.20
± 0.74
Placebo (ITT)
2.05
± 0.84
FEV1 - Month 6 post transplant
Group
Value
95% CI
Repertaxin (ITT)
2.62
± 0.95
Placebo (ITT)
2.34
± 0.85
FEV1 - Month 12 post transplant
Group
Value
95% CI
Repertaxin (ITT)
2.52
± 1.07
Placebo (ITT)
2.22
± 0.95
FVC - Month 1 post transplant
Group
Value
95% CI
Repertaxin (ITT)
2.49
± 0.70
Placebo (ITT)
2.56
± 1.01
FVC - Month 6 post transplant
Group
Value
95% CI
Repertaxin (ITT)
3.19
± 0.93
Placebo (ITT)
3.11
± 0.99
FVC - Month 12 post transplant
Group
Value
95% CI
Repertaxin (ITT)
3.19
± 1.05
Placebo (ITT)
3.07
± 1.10
Number of Patients With Different Bronchiolitis Obliterans Syndrome (BOS) Scores (0-3) Assessed at Months 6 and 12 Post-transplantSecondary· At Months 6 and 12 post-transplant
BOS is defined as an irreversible decline in forced expiratory volume in 1 second (FEV1) of at least 20% from baseline. Spirometric measurements must be made with equipment that conforms to the American Thoracic Society standards for spirometric testing. Here the classification where stage 3 is the worst:
BOS 0 FEV1 \>90% of baseline and FEF25-75 \>75% of baseline. BOS 0-p FEV1 \>81% to 90% of baseline and/or FEF25-75 \> 75% of baseline. BOS 1 FEV1 \>66% to 80% of baseline. BOS 2 FEV1 \>51% to 65% of baseline BOS 3 FEV1 \>50% or less of baseline. CRF data are reported.
Month 6 Post Transplant - BOS Missing
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
4
Month 6 Post Transplant - BOS 0
Group
Value
95% CI
Repertaxin (ITT)
45
Placebo (ITT)
44
Month 6 Post Transplant - BOS 1
Group
Value
95% CI
Repertaxin (ITT)
1
Placebo (ITT)
3
Month 6 Post Transplant - BOS 2
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
1
Month 6 Post Transplant - BOS 3
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
0
Month 12 Post Transplant - Missing
Group
Value
95% CI
Repertaxin (ITT)
4
Placebo (ITT)
7
Month 12 Post Transplant - BOS 0
Group
Value
95% CI
Repertaxin (ITT)
35
Placebo (ITT)
36
Month 12 Post Transplant - BOS 1
Group
Value
95% CI
Repertaxin (ITT)
1
Placebo (ITT)
5
Number of Patients With at Least One Acute Rejection Episode at Months 1, 6 and 12 Post-transplantSecondary· At months 1, 6 and 12 post-transplant
Acute rejection was diagnosed according to Yousem et al. (1996). Histopathologic assessment of transbronchial biopsies first required confirmation of the diagnosis of mild (ACR; A2) using criteria defined in the Working Formulation for Lung Allograft Rejection. Morphological variables assessed included: one or more perivascular infiltrates in the total transbronchial biopsy fragments obtained at one bronchoscopy session, the presence of large or small airway inflammation, endothelialitis, eosinophils, plasma cells, intra-airway and intra-airspace granulation tissue, and alveolar hemosiderosis.
Month 1 Post transplant
Group
Value
95% CI
Repertaxin (ITT)
17
Placebo (ITT)
19
Month 6 Post Transplant
Group
Value
95% CI
Repertaxin (ITT)
35
Placebo (ITT)
33
Month 12 Post Transplant
Group
Value
95% CI
Repertaxin (ITT)
17
Placebo (ITT)
13
Patient Survival up to 12 Months Post-transplantSecondary· at Months 3, 6, 9 and 12 post-transplant
Patient survival is derived from the date of ICU admission untile the date of death or study completion/withdrawal.
Here this parameter is expressed as the "cumulative number of events (death)" at different timepoints till month 12, per arm.
3 Months
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
3
6 Months
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
5
9 Months
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
6
12 Months
Group
Value
95% CI
Repertaxin (ITT)
0
Placebo (ITT)
7
Number of Patients With at Least One Adverse Events Within the First MonthSecondary· to month 1
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number (%) of patients reporting at least one TEAE
Group
Value
95% CI
Repertaxin (SAF)
46
Placebo (SAF)
55
Number (%) of patients reporting at least one TEAE leading to discontinuation of study drug
Group
Value
95% CI
Repertaxin (SAF)
1
Placebo (SAF)
0
Number (%) of patients reporting at least one serious TEAE
Group
Value
95% CI
Repertaxin (SAF)
14
Placebo (SAF)
14
Number (%) of patients reporting at least one TEAE leading to death
Group
Value
95% CI
Repertaxin (SAF)
0
Placebo (SAF)
0
Number (%) of patients reporting TEAEs with no relationship to study drug
Group
Value
95% CI
Repertaxin (SAF)
19
Placebo (SAF)
26
Number (%) of patients reporting TEAEs with unlikely relationship to study drug
Group
Value
95% CI
Repertaxin (SAF)
18
Placebo (SAF)
22
Number (%) of patients reporting TEAEs with possible study drug
Group
Value
95% CI
Repertaxin (SAF)
9
Placebo (SAF)
7
Number (%) of patients reporting TEAEs with probable relationship to study drug
Group
Value
95% CI
Repertaxin (SAF)
0
Placebo (SAF)
0
Number of Patients With at Least One Adverse Events From Month 1 to Month 12Secondary· from month 1 to month 12
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number of patients with TEAEs
Group
Value
95% CI
Repertaxin (SAF)
46
Placebo (SAF)
40
Number (%) of patients reporting at least one TEAE
Group
Value
95% CI
Repertaxin (SAF)
21
Placebo (SAF)
20
Number (%) of patients reporting at least one TEAE leading to discontinuation of study drug
Group
Value
95% CI
Repertaxin (SAF)
0
Placebo (SAF)
0
Number (%) of patients reporting at least one serious TEAE
Group
Value
95% CI
Repertaxin (SAF)
0
Placebo (SAF)
0
Number (%) of patients reporting at least one TEAE leading to death
Group
Value
95% CI
Repertaxin (SAF)
0
Placebo (SAF)
0
Number (%) of patients reporting TEAEs with no relationship to study drug
Group
Value
95% CI
Repertaxin (SAF)
11
Placebo (SAF)
9
Number (%) of patients reporting TEAEs with unlikely relationship to study drug
Group
Value
95% CI
Repertaxin (SAF)
9
Placebo (SAF)
8
Number (%) of patients reporting TEAEs with possible relationship to study drug
Group
Value
95% CI
Repertaxin (SAF)
1
Placebo (SAF)
3
Adverse events — posted to ClinicalTrials.gov
Time frame: The specific period of time over which adverse events data were collected was from the start of infusion to Month 12 visit. Note that in Placebo population the number of subject was 52 instead of 55 in the period from Month 1 to Month 12..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Repertaxin (SAF)
Serious: 14/46 (30%)
Deaths: 1/46
Placebo (SAF)
Serious: 14/55 (25%)
Deaths: 6/55
Serious adverse events (30 terms)
Reaction
System
Repertaxin (SAF)
Placebo (SAF)
Coagulopathy
Blood and lymphatic system disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
—
Haemorrage
Vascular disorders
—
—
Hypotension
Vascular disorders
—
—
Lung transplant rejection
Immune system disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
—
—
Reperfusion injury
Vascular disorders
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
Atrial flutter
Cardiac disorders
—
—
Cardiac arrest
Cardiac disorders
—
—
Cardiac tamponade
Cardiac disorders
—
—
Cardiopulmonary failure
Cardiac disorders
—
—
Pericarditis
Cardiac disorders
—
—
Supraventricular Tachycardia
Cardiac disorders
—
—
Cytokine release Syndrome
Immune system disorders
—
—
Pneumonia
Infections and infestations
—
—
Graft dysfunction
Injury, poisoning and procedural complications
—
—
Post procedural haemorrhage
Injury, poisoning and procedural complications
—
—
Oxygen saturation decreased
Investigations
—
—
Depressed level of consciousness
Nervous system disorders
—
—
Hemiparesis
Nervous system disorders
—
—
Vocal cord paralysis
Nervous system disorders
—
—
Renal failure
Renal and urinary disorders
—
—
Other adverse events (204 terms — click to expand)
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 \[formerly interleukin (IL)-8\]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved functional and clinical outcomes in lung transplantation patients.
The safety of repertaxin in the specific clinical setting was also evaluated.
The ability of repertaxin to reduce target cells (polymorphonuclear leukocyte \[PMN\]) infiltration into the graft was evaluated to confirm its mechanism of action.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dompé Farmaceutici S.p.A
Last refreshed: 11 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00224406.