An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis
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|ClinicalTrials.gov Identifier: NCT03088111|
Recruitment Status : Not yet recruiting
First Posted : March 23, 2017
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infection, Bacterial Anthrax||Other: Collection of samples Biological: Obiltoxaximab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|Official Title:||A Phase 4, Open Label Field Study to Evaluate the Clinical Benefit, Safety, and Pharmacokinetics of Anthim (Obiltoxaximab) When Used in the Treatment of Suspected, Probable, or Confirmed Cases of Inhalational Anthrax Due to B. Anthracis|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
This is an open label, 24-week, single arm field study that will be implemented for subjects who receive FDA-approved obiltoxaximab as part of their medical treatment for inhalational anthrax infection in the United States. Adult subjects will be administered a single, intravenous (IV) dose of 16 mg/kg obiltoxaximab given as part of their medical care. Children will receive a weight-adjusted dose.
The primary purpose of the study is to collect data from subjects who have been treated with obiltoxaximab as part of their medical care for inhalational anthrax and to collect additional blood samples for measurement of obiltoxaximab concentrations and presence of anti-therapeutic antibodies (ATA).
Other: Collection of samples
To the extent possible, blood samples will be collected from all subjects prior to infusion and at specified time points post-infusion to determine serum obiltoxaximab concentrations and ATA titers. Scavenged blood samples can be utilized, if acceptable, to maximize sample analyses for pharmacokinetic and other investigational parameters. Data on other relevant laboratory testing will only be collected and evaluated if available in the subject's record (eg, protective antigen (PA), anti-PA, anti-lethal factor (LF), anti-edema factor, IgG antibodies, anthrax lethal toxin neutralizing activity, presence of anthrax LF, incidence and duration of B. anthracis bacteremia, and demonstration of B. anthracis antigens in tissues).
Obiltoxaximab standard of care
Other Name: Anthim
- Overall survival in suspected, probable, or confirmed cases of inhalational anthrax at Week 24 [ Time Frame: Up to Week 24 ]Overall survival will be summarized by frequency of subjects who completed the study at Week 24, and subjects who died before that visit. Population survival distribution function (SDF) will be estimated using the Kaplan-Meier (KM) method.
- Survival at Day 14 and Day 28 [ Time Frame: Up to Day 28 ]Population survival rates at 14 and 28 days will be estimated using the KM method.
- Duration of survival (to Week 24) [ Time Frame: Up to Week 24 ]The KM method will be used to estimate duration of survival.
- Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24) [ Time Frame: Up to Week 24 ]The progression to systemic anthrax infection and complication rates will be summarized using KM estimates associated with time to disease progression and time to complication of anthrax. The population SDFs of time to progression to systemic anthrax infection and of time to complication will be estimated using the KM method. Summary statistics of subjects with disease progression and complication rates will be provided.
- Modified SOFA score (to Week 24) [ Time Frame: Up to Week 24 ]Modified sequential organ failure assessment (SOFA) scores will be assessed using 5 organ systems (respiratory, liver, cardiovascular, central nervous system, renal).
- Incidence and duration of B. anthracis bacteremia [ Time Frame: Up to Week 24 ]Incidence and duration of B. anthracis bacteremia will be summarized by total incidence across time points of subjects with bacteremia and time from study drug administration to onset of bacteremia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088111
|Contact: : Angela Williamsonemail@example.com|
|Contact: Steven Warthanfirstname.lastname@example.org|
|Study Director:||Christa Nagy, PhD||Elusys Therapeutics, Inc.|
|Study Director:||Timothy S. Leach, MD, MPH||Contract Medical Monitor|