Trial reportBMC pulmonary medicine2012
A phase I study evaluating the pharmacokinetics, safety and tolerability of an antibody-based tissue factor antagonist in subjects with acute lung injury or acute respiratory distress syndrome.
Trial report in BMC pulmonary medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01438853 (The Safety, Pharmacokinetics, and Pharmacodynamic Effects of TNX-832), which is not on this map. Cited by 21 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Safety, Pharmacokinetics, and Pharmacodynamic Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
Who cites it
21 citing papers in PubMed, 40 citations in OpenAlex.
- Lung-Cardiovascular Interactions and Derangements in ARDS.Comprehensive physiology · 2026Review
- Circulating and Respiratory Biomarkers in Sepsis-Induced ARDS: Diagnostic and Prognostic Insights - A Narrative Review.Journal of inflammation research · 2026Review
- The Role of Tissue Factor In Signaling Pathways of Pathological Conditions and Angiogenesis.Current molecular medicine · 2024Review
- Ameliorating effects of berberine on sepsis-associated lung inflammation induced by lipopolysaccharide: molecular mechanisms and preclinical evidence.Pharmacological reports : PR · 2023Review
- Tissue factor (coagulation factor III): a potential double-edge molecule to be targeted and re-targeted toward cancer.Biomarker research · 2023Review
- The Protective Effect of Sulodexide on Acute Lung Injury Induced by a Murine Model of Obstructive Jaundice.BioMed research international · 2022Article
- Functional Characteristics and Regulated Expression of Alternatively Spliced Tissue Factor: An Update.Cancers · 2021Review
- Nanotherapeutics in the treatment of acute respiratory distress syndrome.Life sciences · 2021Review
- Airway Redox Homeostasis and Inflammation Gone Awry: From Molecular Pathogenesis to Emerging Therapeutics in Respiratory Pathology.International journal of molecular sciences · 2020Review
- Emerging pharmacological therapies for ARDS: COVID-19 and beyond.Intensive care medicine · 2020Article
- Article
- MiR-216a alleviates LPS-induced acute lung injury via regulating JAK2/STAT3 and NF-κB signaling.Human cell · 2020Article
- ImmunoPET imaging of tissue factor expression in pancreatic cancer withJournal of controlled release : official journal of the Controlled Release Society · 2017Article
- [Acute respiratory distress syndrome : Basic principles and treatment].Der Anaesthesist · 2017Review
- Tissue factor-specific ultra-bright SERRS nanostars for Raman detection of pulmonary micrometastases.Nanoscale · 2017Article
- Sepsis and septic shock.Nature reviews. Disease primers · 2016Review
- Tumour imaging by the detection of fibrin clots in tumour stroma using an anti-fibrin Fab fragment.Scientific reports · 2016Article
- Utility of epirubicin-incorporating micelles tagged with anti-tissue factor antibody clone with no anticoagulant effect.Cancer science · 2016Article
- Genetic variation in the tissue factor gene is associated with clinical outcome in severe sepsis patients.Critical care (London, England) · 2014Article
- Tissue factor as a novel target for treatment of breast cancer.The oncologist · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundThe tissue factor (TF)-dependent extrinsic pathway has been suggested to be a central mechanism by which the coagulation cascade is locally activated in the lungs of patients with acute lung injury and acute respiratory distress syndrome (ALI/ARDS) and thus represents an attractive target for therapeutic intervention. This study was designed to determine the pharmacokinetic and safety profiles of ALT-836, an anti-TF antibody, in patients with ALI/ARDS.
methodsThis was a prospective, randomized, placebo-controlled, dose-escalation Phase I clinical trial in adult patients who had suspected or proven infection, were receiving mechanical ventilation and had ALI/ARDS (PaO(2)/FiO(2) ≤ 300 mm). Eighteen patients (6 per cohort) were randomized in a 5:1 ratio to receive ALT-836 or placebo, and were treated within 48 hours after meeting screening criteria. Cohorts of patients were administered a single intravenously dose of 0.06, 0.08 or 0.1 mg/kg ALT-836 or placebo. Blood samples were taken for pharmacokinetic and immunogenicity measurements. Safety was assessed by adverse events, vital signs, ECGs, laboratory, coagulation and pulmonary function parameters.
resultsPharmacokinetic analysis showed a dose dependent exposure to ALT-836 across the infusion range of 0.06 to 0.1 mg/kg. No anti-ALT-836 antibody response was observed in the study population during the trial. No major bleeding episodes were reported in the ALT-836 treated patients. The most frequent adverse events were anemia, observed in both placebo and ALT-836 treated patients, and ALT-836 dose dependent, self-resolved hematuria, which suggested 0.08 mg/kg as an acceptable dose level of ALT-836 in this patient population.
conclusionsOverall, this study showed that ALT-836 could be safely administered to patients with sepsis-induced ALI/ARDS.
trial registrationClinicalTrials.gov: NCT01438853.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.