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SepsisPhase 2NCT00879606

Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome

A Phase 2 study testing ALT-836 in people with Sepsis and Acute Lung Injury, run by Altor BioScience at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ALT-836
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
20 sitesUnited States
Study dates
Apr 2009to Jan 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • <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%
Show all 31Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • Piedmont Respiratory Research Foundation

    Greensboro, North Carolina, 27310

  • Kentucky Lung Clinic

    Hazard, Kentucky, 41701

  • University of Iowa

    Iowa City, Iowa, 52246

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Los Angeles County and USC Medical Center

    Los Angeles, California, 90033

  • University of Louisville-Division of Pulmonary and Critical Care

    Louisville, Kentucky, 40202

  • Yale University

    New Haven, Connecticut, 06520

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • West Suburban Hospital Medical Center

    Oak Park, Illinois, 60302

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Illinois Lung and Critical Care Institute

    Peoria, Illinois, 61606

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Saint Louis University

    St Louis, Missouri, 63110

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Stanford University

    Stanford, California, 94305

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
ALT-836, Placebo
Keywords
Sepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome, ALI/ARDS, Lung Disease
Medical subject headings
Sepsis, Acute Lung Injury, Respiratory Distress Syndrome, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALT-836Drug

    Also called Formerly TNX-832; Sunol-cH36

    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.

  • PlaceboDrug

    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.

Study groups in NCT00879606
Study groupRoleWhat they receive
1ExperimentalParticipants will be randomized to receive ALT-836.
Receives: Drug: ALT-836
2Placebo comparatorPatients will be randomized to receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety profile of the study drug

    Measured: Throughout the 28 days following treatment

  2. Number of ventilator-free days at Day 28

    Measured: Determined at Day 28

Secondary outcomes (9)

  1. Mortality at Day 7, 14, 21, 28 and 60

    Measured: Determined at Day 7, 14, 21, 28 and 60

  2. Length of hospitalization at Day 28

    Measured: Determined at Day 28

  3. Length of ICU stay at Day 28

    Measured: Determined at Day 28

  4. Number of Non-pulmonary organ failure free days at Day 28

    Measured: Determined at Day 28

  5. Changes in physiological variables of lung injury

    Measured: Throughout the 28 days following treatment

  6. Changes in disease severity and lung injury scores

    Measured: Throughout the 28 days following treatment

  7. Effects of the study drug and the etiology of the disease (i.e. pulmonary or extra-pulmonary origin)

    Measured: Determined at Day 28

  8. Pharmacokinetics & Pharmacodynamics

    Measured: Throughout the 28 days following treatment

  9. Immunogenicity

    Measured: Throughout the 28 days following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00879606
Sponsor's protocol ID
CA-ALT-836-01-08
Other IDs
NHLBI/NIH-5R44HL082397-03
Status last verified
Mar 2015
First submitted
8 Apr 2009
Last updated
10 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Morris PE, Steingrub JS, Huang BY, Tang S, Liu PM, Rhode PR, Wong HC. 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. BMC Pulm Med. 2012 Feb 16;12:5. doi: 10.1186/1471-2466-12-5.

    PubMed 22340260

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALT-836 in people with Sepsis and Acute Lung Injury, run by Altor BioScience at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety profile of the study drug (time frame: Throughout the 28 days following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00879606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.

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