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NCT01438853 · ClinicalTrials.gov registry record · Phase 1
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
A Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome, sponsored by Altor BioScience.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 7
- Study locations
NCT01438853: Completed Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome, sponsored by Altor BioScience.
NCT01438853 is a Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome that has completed, run by Altor BioScience. The registered enrollment target is 18 participants, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01438853, a Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome, has completed, sponsored by Altor BioScience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 7
- Study locations
Study Summary
This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15 minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics of the study treatment were evaluated.
Primary Outcome
To evaluate the safety of escalating dose levels of TNX-832 in subjects with suspected or proven bacteria-induced ALI/ARDS. Safety was assessed by number of treatment emergent adverse events, and changes in vital signs, ECGs, laboratory, coagulation and pulmonary function parameters from baseline. Immunogenicity (serum anti-TNX-832 antibody response) was evalutated.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL TNX-832
Study Locations (7)
Florida
- University of Miami - Miami
Massachusetts
- Beth Israel Deconess Medical Center - Boston
Missouri
- Washington University - St Louis
North Carolina
- Wake Forest University - Winston-Salem
Ohio
- Akron General Medical Center - Akron
Texas
- Baylor School of Medicine - Houston
Nova Scotia
- Capital Health - Halifax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-12 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
What the finished NCT01438853 record still lists
NCT01438853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01438853 lists 7 locations in 7 states (Florida, Massachusetts, Missouri).
Frequently Asked Questions
What is clinical trial NCT01438853 about?
NCT01438853 is a clinical study titled "Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome". This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least six subjects each were originally planned...
What is the current status of trial NCT01438853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2004-12. Estimated completion is 2008-02.
What conditions does trial NCT01438853 study?
This clinical trial studies the following conditions: Sepsis, Acute Respiratory Distress Syndrome, Acute Lung Injury.
What interventions are being tested in trial NCT01438853?
The interventions under investigation include: Placebo (DRUG), TNX-832 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01438853?
This trial is sponsored by Altor BioScience, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01438853 being conducted?
This trial has 7 study locations across Florida, Massachusetts, Missouri, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01438853's enrollment target sits among peer trials
18 83rd of 90 higher than 7 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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