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Antiplasmin Inactivator
TS23 for Pulmonary Embolism (NAIL-IT Trial)
Phase 2
Recruiting
Led By Guy L Reed, MD
Research Sponsored by Translational Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is hemodynamically stable with a systolic blood pressure (SBP) >90 mm Hg
Subject has evidence of RV dysfunction as indicated by a right ventricular-to-left ventricular (RV/LV) diameter ratio > 0.9 on CTPA scan (measuring the minor axis of the right and left ventricle in the transverse plane), prior to the initiation of study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours after treatment
Awards & highlights
NAIL-IT Trial Summary
This trial tests a potential new treatment for cancer. Results will be used to decide if it's safe and effective.
Who is the study for?
This trial is for adults over 18 with a recent pulmonary embolism (PE) confirmed by scan, showing specific heart dysfunction but stable blood pressure. It's not for those at high bleeding risk, with certain liver conditions, low blood counts, or severe kidney issues. Pregnant or breastfeeding women and those not using effective birth control are excluded.Check my eligibility
What is being tested?
The NAIL-IT Trial is testing TS23 against a placebo in phase II to see if it can safely dissolve blood clots in the lungs. Participants will be randomly assigned to either the drug or placebo group.See study design
What are the potential side effects?
While side effects of TS23 aren't detailed here, common risks may include bleeding due to clot breakdown and potential allergic reactions to new medications.
NAIL-IT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is stable and above 90 mm Hg.
Select...
My heart scan shows right ventricle enlargement compared to the left.
NAIL-IT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RV/LV
Safety- Bleeding
Secondary outcome measures
Thrombus dissolution
NAIL-IT Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Low dose TS23Experimental Treatment1 Intervention
TS23 low dose + SOC anticoagulation
Group II: Intermediate dose TS23Experimental Treatment1 Intervention
TS23 medium dose + SOC anticoagulation
Group III: Higher dose TS23Experimental Treatment1 Intervention
TS23 highest dose + SOC anticoagulation
Group IV: PlaceboPlacebo Group1 Intervention
Placebo + standard of care (SOC) anticoagulation
Find a Location
Who is running the clinical trial?
Translational Sciences, Inc.Lead Sponsor
2 Previous Clinical Trials
324 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
24 Patients Enrolled for Pulmonary Embolism
Guy L Reed, MDPrincipal InvestigatorTranslational Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of testing positive for Hepatitis B or Hepatitis C.My blood pressure is stable and above 90 mm Hg.My liver is healthy and my liver enzyme levels are not three times above the normal limit.I have a bleeding disorder that makes me bleed easily.I need to take two different blood-thinning medications at the same time.I cannot take standard blood thinners or certain medications due to allergies or reactions.I haven't had major surgery, significant head injury, or a stroke in the last 3 months.I am not pregnant, not breastfeeding, and willing to use effective birth control.I was diagnosed with a lung clot in a major artery less than 5 days ago.I have been on blood thinners like heparin or LMWH for at least 48 hours.Your hemoglobin level is less than 8.0 grams per deciliter.I have had a brain bleed, brain vessel malformation, or aneurysm.You are not expected to live for more than 6 months.Your blood platelet count is less than 100,000 per microliter.My heart scan shows right ventricle enlargement compared to the left.I am over 18 years old.My kidney function is low, with a creatinine clearance less than 30 mL/min or serum creatinine ≥ 2.5 mg/dL.Your blood pressure is very high and not well controlled.You have previously tested positive for HIV.I am planned for or have had clot-dissolving treatment recently.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Low dose TS23
- Group 3: Intermediate dose TS23
- Group 4: Higher dose TS23
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Intermediate dose TS23 attained FDA approval?
"According to our team's evaluation, intermediate dose TS23 scored a 2 in terms of safety since it is currently undergoing Phase 2 trials and though there may be some evidence suggesting its security, efficacy has yet to be established."
Answered by AI
Are there any open opportunities for participation in the research study at present?
"Clinicaltrials.gov reports that this clinical trial is currently seeking participants, with its first posting on May 24th 2023 and most recent edit being made July 8th."
Answered by AI
How extensive is the participant base for this clinical experiment?
"Affirmative. The details provided on clinicaltrials.gov state that this medical experiment, which was first uploaded to the website on May 24th 2023, is actively seeking for participants. 32 individuals will be recruited from one participating facility."
Answered by AI
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