- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00879606
Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
20. mars 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
150
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Los Angeles, California, Forente stater, 90033
- Los Angeles County and USC Medical Center
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Sacramento, California, Forente stater, 95817
- UC Davis Medical Center
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Stanford, California, Forente stater, 94305
- Stanford University
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Connecticut
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New Haven, Connecticut, Forente stater, 06520
- Yale University
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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Oak Park, Illinois, Forente stater, 60302
- West Suburban Hospital Medical Center
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Peoria, Illinois, Forente stater, 61606
- Illinois Lung and Critical Care Institute
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Iowa
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Iowa City, Iowa, Forente stater, 52246
- University of Iowa
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Kentucky
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Hazard, Kentucky, Forente stater, 41701
- Kentucky Lung Clinic
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Louisville, Kentucky, Forente stater, 40202
- University of Louisville-Division of Pulmonary and Critical Care
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Massachusetts
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Springfield, Massachusetts, Forente stater, 01199
- Baystate Medical Center
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- Saint Luke's Hospital
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St. Louis, Missouri, Forente stater, 63110
- Saint Louis University
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St. Louis, Missouri, Forente stater, 63141
- Mercy Hospital St. Louis
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New York
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New York, New York, Forente stater, 10065
- Memorial Sloan-Kettering Cancer Center
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New York City, New York, Forente stater, 10029
- Mount Sinai Medical Center
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North Carolina
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Charlotte, North Carolina, Forente stater, 28203
- Carolinas Medical Center
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Greensboro, North Carolina, Forente stater, 27310
- Piedmont Respiratory Research Foundation
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- University of Oklahoma
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Safety profile of the study drug
Tidsramme: 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
Tidsramme: Determined at Day 28
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Determined at Day 28
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Mortality at Day 7, 14, 21, 28 and 60
Tidsramme: 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
Tidsramme: Determined at Day 28
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Determined at Day 28
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Length of ICU stay at Day 28
Tidsramme: 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
Tidsramme: Determined at Day 28
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Determined at Day 28
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Changes in physiological variables of lung injury
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Determined at Day 28
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Determined at Day 28
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Pharmacokinetics & Pharmacodynamics
Tidsramme: Throughout the 28 days following treatment
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Throughout the 28 days following treatment
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Immunogenicity
Tidsramme: Throughout the 28 days following treatment
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Throughout the 28 days following treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Hing C Wong, PhD, Altor BioScience
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2009
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først innsendt
8. april 2009
Først innsendt som oppfylte QC-kriteriene
8. april 2009
Først lagt ut (Anslag)
10. april 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Infeksjoner
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Lungesykdommer
- Systemisk inflammatorisk responssyndrom
- Betennelse
- Sykdom
- Spedbarn, nyfødte, sykdommer
- Spedbarn, premature, sykdommer
- Thoracale skader
- Sepsis
- Syndrom
- Sår og skader
- Respiratorisk distress syndrom
- Respiratorisk distress syndrom, nyfødt
- Akutt lungeskade
- Lungeskade
Andre studie-ID-numre
- CA-ALT-836-01-08
- NHLBI/NIH-5R44HL082397-03
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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