- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00879606
Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
20 marzo 2015 aggiornato da: Altor BioScience
Efficacy and Safety Evaluation of ALT-836 in Patients With Sepsis and Acute Lung Injury/Acute Respiratory Distress Syndrome
This is a prospective, randomized (1:1), double-blind, multi-center, Phase II clinical study to test the safety and efficacy of a recombinant chimeric anti-tissue factor antibody (ALT-836) versus placebo in patients with sepsis and acute lung injury/acute respiratory distress syndrome (ALI/ARDS).
This study was divided into two parts and the first part of the study has been completed.
In the first part of the study, sixty patients were randomized at a 1:1 ratio to receive one dose of the study drug or placebo.
In the second part of the study, ninety patients will be randomized at a 1:1 ratio to receive a multi-dose treatment regimen of single doses every 72 hours up to a maximum of 4 doses of the study drug or placebo, provided there are no safety concerns.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
Tissue factor (TF)-dependent procoagulant activity and associated inflammatory processes may play a role in the severity and progression of ALI/ARDS.
Recent studies demonstrated that TF levels were elevated in plasma and pulmonary edema fluid of ARDS/ALI patients compared to control patients with hydrostatic pulmonary edema.
These higher plasma TF levels were correlated with increased mortality, fewer ventilation-free days, the presence of disseminated intravascular coagulation and the presence of sepsis in patients with ALI/ARDS, suggesting that systemic activation of coagulation may be clinically important in ALI/ARDS.
Moreover, the pulmonary TF levels in patients with ALI/ARDS were found to range between 0.5 and 2 nM, approximately 100-fold higher than simultaneous plasma levels, suggesting an intra-alveolar source of TF.
Thus, anti-TF antibody blockage of TF activity may therefore provide an effective therapeutic mechanism for the treatment of inflammatory disorders such as ALI and ARDS.
This study will test the hypothesis that administration of anti-TF antibody (ALT-836) to septic patients with ALI/ARDS will improve the clinical outcome by shortening the duration of mechanical ventilation for these patients.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
150
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90033
- Los Angeles County and USC Medical Center
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Sacramento, California, Stati Uniti, 95817
- UC Davis Medical Center
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Stanford, California, Stati Uniti, 94305
- Stanford University
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520
- Yale University
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern University
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Oak Park, Illinois, Stati Uniti, 60302
- West Suburban Hospital Medical Center
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Peoria, Illinois, Stati Uniti, 61606
- Illinois Lung and Critical Care Institute
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Iowa
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Iowa City, Iowa, Stati Uniti, 52246
- University of Iowa
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Kentucky
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Hazard, Kentucky, Stati Uniti, 41701
- Kentucky Lung Clinic
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Louisville, Kentucky, Stati Uniti, 40202
- University of Louisville-Division of Pulmonary and Critical Care
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Massachusetts
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Springfield, Massachusetts, Stati Uniti, 01199
- Baystate Medical Center
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Missouri
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Kansas City, Missouri, Stati Uniti, 64111
- Saint Luke's Hospital
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St. Louis, Missouri, Stati Uniti, 63110
- Saint Louis University
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St. Louis, Missouri, Stati Uniti, 63141
- Mercy Hospital St. Louis
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New York
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New York, New York, Stati Uniti, 10065
- Memorial Sloan-Kettering Cancer Center
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New York City, New York, Stati Uniti, 10029
- Mount Sinai Medical Center
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28203
- Carolinas Medical Center
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Greensboro, North Carolina, Stati Uniti, 27310
- Piedmont Respiratory Research Foundation
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- University of Oklahoma
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
INCLUSION CRITERIA:
- Suspected or proven infection
- Hypoxemia: PaO2/FiO2is ≤300 mm Hg
- Bilateral infiltrates consistent with pulmonary edema
- Positive-pressure mechanical ventilation through an endotracheal tube
- No clinical evidence of left atrial hypertension to explain bilateral infiltrates
- Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC
Criteria 2 and 3 must occur within a 24-hour interval. The 48-hour enrollment time window begins when criteria 2, 3, and 4 are met.
EXCLUSION CRITERIA:
- <18 years
- Inability to obtain consent
- Patient, surrogate, or physician not committed to full support
- Moribund state in which death was perceived to be imminent
- Morbid obesity
- Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be >50%
- Known HIV positive with known end stage processes
- Prior cardiac arrest requiring CPR without fully demonstrated neurological recovery; or New York Heart Association Class IV
- Pregnant or nursing
- ALI/ARDS induced by mechanical or chemical injury directly to the lung (including burns, trauma, and near drowning)
- >48 hours since all inclusion criteria are met
- Neuromuscular disease that impairs ability to ventilate without assistance
- Severe chronic respiratory disease, severe pulmonary hypertension, or ventilator dependency
- Chest wall deformity resulting in severe exercise restriction, secondary polycythemia, or respirator dependent
- History of organ transplant (including bone marrow)
- Severe chronic liver disease, as determined by a Child-Pugh Score >10
- Hemoglobin persistently < 7.0 g/dL
- Platelet count <50,000/mm3
- Prolonged INR >3
- Bleeding disorders unless corrective surgery has been performed
- Active internal bleeding
- Major surgery within 24 hours before study drug infusion, or evidence of active bleeding postoperatively, or plan for any major surgery within 3 days after study drug infusion.
- Diffuse alveolar hemorrhage from vasculitis
- Known bleeding diathesis
- Presence of an epidural catheter or lumbar puncture within 48 hours before study drug infusion or anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after study drug infusion
- Stroke within 3 months of study entry
- Trauma with an increased risk of life-threatening bleeding
- A history of severe head trauma that required hospitalization, or intracranial surgery within two months of study entry
- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion
- Uses of certain medications or treatment regimens such as chemotherapy, unfractionated heparin, low-molecular-weight heparin, Warfarin, antithrombin III, acetylsalicylic acid, glycoprotein IIb/IIIa antagonists, thrombolytic therapy, and activated Protein C are restricted.
- Participation in another experimental medication study within 30 days of study entry.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 1
Participants will be randomized to receive ALT-836.
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In the first part of this study, recombinant chimeric anti-tissue factor antibody ALT-836 was administered as a single dose (0.06 mg/Kg) via intravenous infusion over 15 minutes.
In the second part of this study, up to four doses (0.06 mg/Kg) of ALT-836 will be administered via intravenous infusion over 15 minutes.
Altri nomi:
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Comparatore placebo: 2
Patients will be randomized to receive placebo.
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In the first part of this study, a single dose of Placebo was administered via intravenous infusion over 15 minutes.
In the second part of this study, up to four doses of Placebo will be administered via intravenous infusion over 15 minutes.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Safety profile of the study drug
Lasso di tempo: Throughout the 28 days following treatment
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Throughout the 28 days following treatment
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Number of ventilator-free days at Day 28
Lasso di tempo: Determined at Day 28
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Determined at Day 28
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Mortality at Day 7, 14, 21, 28 and 60
Lasso di tempo: Determined at Day 7, 14, 21, 28 and 60
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Determined at Day 7, 14, 21, 28 and 60
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Length of hospitalization at Day 28
Lasso di tempo: Determined at Day 28
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Determined at Day 28
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Length of ICU stay at Day 28
Lasso di tempo: Determined at Day 28
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Determined at Day 28
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Number of Non-pulmonary organ failure free days at Day 28
Lasso di tempo: Determined at Day 28
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Determined at Day 28
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Changes in physiological variables of lung injury
Lasso di tempo: Throughout the 28 days following treatment
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Throughout the 28 days following treatment
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Changes in disease severity and lung injury scores
Lasso di tempo: Throughout the 28 days following treatment
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Throughout the 28 days following treatment
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Effects of the study drug and the etiology of the disease (i.e. pulmonary or extra-pulmonary origin)
Lasso di tempo: Determined at Day 28
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Determined at Day 28
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Pharmacokinetics & Pharmacodynamics
Lasso di tempo: Throughout the 28 days following treatment
|
Throughout the 28 days following treatment
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Immunogenicity
Lasso di tempo: Throughout the 28 days following treatment
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Throughout the 28 days following treatment
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Hing C Wong, PhD, Altor BioScience
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2009
Completamento primario (Effettivo)
1 ottobre 2012
Completamento dello studio (Effettivo)
1 gennaio 2013
Date di iscrizione allo studio
Primo inviato
8 aprile 2009
Primo inviato che soddisfa i criteri di controllo qualità
8 aprile 2009
Primo Inserito (Stima)
10 aprile 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
10 aprile 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 marzo 2015
Ultimo verificato
1 marzo 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Infezioni
- Malattie delle vie respiratorie
- Disturbi respiratori
- Malattie polmonari
- Sindrome da risposta infiammatoria sistemica
- Infiammazione
- Patologia
- Infante, neonato, malattie
- Infantile, prematuro, malattie
- Lesioni toraciche
- Sepsi
- Sindrome
- Ferite e lesioni
- Sindrome da stress respiratorio
- Sindrome da distress respiratorio, neonato
- Lesioni polmonari acute
- Lesione polmonare
Altri numeri di identificazione dello studio
- CA-ALT-836-01-08
- NHLBI/NIH-5R44HL082397-03
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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-
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