- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00879606
Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
20. marts 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
150
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90033
- Los Angeles County and USC Medical Center
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Sacramento, California, Forenede Stater, 95817
- UC Davis Medical Center
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Stanford, California, Forenede Stater, 94305
- Stanford University
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Oak Park, Illinois, Forenede Stater, 60302
- West Suburban Hospital Medical Center
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Peoria, Illinois, Forenede Stater, 61606
- Illinois Lung and Critical Care Institute
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Iowa
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Iowa City, Iowa, Forenede Stater, 52246
- University of Iowa
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Kentucky
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Hazard, Kentucky, Forenede Stater, 41701
- Kentucky Lung Clinic
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Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville-Division of Pulmonary and Critical Care
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Massachusetts
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Springfield, Massachusetts, Forenede Stater, 01199
- Baystate Medical Center
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
- Saint Luke's Hospital
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St. Louis, Missouri, Forenede Stater, 63110
- Saint Louis University
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St. Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital St. Louis
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New York
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
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New York City, New York, Forenede Stater, 10029
- Mount Sinai Medical Center
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28203
- Carolinas Medical Center
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Greensboro, North Carolina, Forenede Stater, 27310
- Piedmont Respiratory Research Foundation
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 navne:
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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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Hvad måler undersøgelsen?
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Hing C Wong, PhD, Altor BioScience
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2009
Primær færdiggørelse (Faktiske)
1. oktober 2012
Studieafslutning (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først indsendt
8. april 2009
Først indsendt, der opfyldte QC-kriterier
8. april 2009
Først opslået (Skøn)
10. april 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Infektioner
- Luftvejssygdomme
- Respirationsforstyrrelser
- Lungesygdomme
- Systemisk inflammatorisk responssyndrom
- Betændelse
- Sygdom
- Spædbarn, Nyfødt, Sygdomme
- Spædbørn, for tidligt fødte, Sygdomme
- Thoracale skader
- Sepsis
- Syndrom
- Sår og skader
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, nyfødt
- Akut lungeskade
- Lungeskade
Andre undersøgelses-id-numre
- CA-ALT-836-01-08
- NHLBI/NIH-5R44HL082397-03
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Sepsis
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University of Kansas Medical CenterUniversity of KansasRekrutteringSepsis | Septisk chok | Sepsis syndrom | Sepsis, svær | Sepsis bakteriel | Sepsis BakteriæmiForenede Stater
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Jip GroenInBiomeRekrutteringMikrobiel kolonisering | Neonatal infektion | Neonatal sepsis, tidligt opstået | Mikrobiel sygdom | Klinisk sepsis | Kultur Negativ Neonatal Sepsis | Neonatal sepsis, sent opstået | Kultur Positiv Neonatal SepsisHolland
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The University of QueenslandRoyal Brisbane and Women's HospitalUkendt
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Karolinska InstitutetÖrebro University, SwedenAfsluttetSepsis | Sepsis syndrom | Sepsis, sværSverige
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Ohio State UniversityAfsluttetSepsis, Svær Sepsis og Septisk ShockForenede Stater
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Sepsis syndromDet Forenede Kongerige
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Indonesia UniversityAfsluttetAlvorlig sepsis med septisk stød | Alvorlig sepsis uden septisk stødIndonesien
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Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityTilmelding efter invitationAlvorlig sepsis | Alvorlig sepsis uden septisk stødForenede Stater
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Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian... og andre samarbejdspartnereAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Infektion | Sepsis syndromForenede Stater
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Inverness Medical InnovationsAfsluttetSepsis | Systemisk inflammatorisk responssyndrom | Alvorlig sepsis | Sepsis syndromForenede Stater
Kliniske forsøg med ALT-836
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Arbutus Biopharma CorporationAfsluttetKronisk hepatitisKorea, Republikken, Hong Kong, Thailand, Canada, Australien, Moldova, Republikken, New Zealand, Ukraine
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Altor BioScienceGenentech, Inc.; TanoxAfsluttetSepsis | Acute respiratory distress syndrom | Akut lungeskadeForenede Stater, Canada
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Altor BioScienceAfsluttetOndartet fast tumor | Lokalt avanceret malignt neoplasmaForenede Stater