Experimental antidote for blood thinners tested in early trial
NCT ID NCT04593784
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested a drug called ciraparantag to see if it could quickly reverse the effects of blood thinners in 41 healthy adults. Participants received either ciraparantag or a placebo, and their blood clotting time was measured. The study was terminated early, so the full results are not available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ciraparantag (a drug given intravenously to reverse the effects of blood thinners)
- What this could lead to
- If successful, ciraparantag could become a quick-acting antidote for certain blood thinners, potentially helping in emergencies where rapid reversal is needed.
- What could go wrong
- This was an early-phase trial in healthy volunteers, not patients. The study was terminated, so results are limited. It is unclear if it will work in real-world bleeding emergencies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
41 people
The number who actually took part.
- Started
-
Oct 2021
- Finished
-
Aug 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provide written informed consent. 2. 18 to 75 years of age. 3. Be in generally good health 4. BMI 18 to 32 kg/m2, inclusive, at Screening. 5. If female, be surgically sterile or post-menopausal or if of child-bearing potential, using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1. 6. If male, be surgically sterile, or agree to use appropriate contraception. 7. Have suitable venous access for multiple venipunctures. Exclusion Criteria: 1. Have any of the following findings at Screening: 1. Hemoglobin or hematocrit value outside the normal range 2. Platelet count outside the normal range 3. PT or aPTT outside the normal range 4. Plasma fibrinogen outside the normal range 5. Serum triglycerides or total cholesterol outside the normal range 6. Serum creatinine \>1.5 mg/dL (133 μmol/L) or known renal disease 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 x the upper limit of normal, or known liver disease 8. Total bilirubin outside the normal range 9. Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) 10. Positive pregnancy test (females) 11. Positive drug, tobacco or alcohol screen 12. Any clinically significant findings on 12-lead ECG or urinalysis 2. Have a personal or family history of clotting disorder or hematologic abnormality. 3. Have a history of unexplained syncope. 4. Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure of any type, or vaginal delivery 5. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding. 6. Have received any blood product or anticoagulant within 3 months prior to Screening. 7. Have donated blood or blood products within 3 months prior to Screening 8. Have a history of minor bleeding episodes within 1 month prior to Screening, or a long-standing history of such bleeding. 9. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy). 10. Have used any tobacco or nicotine-containing products within 3 months prior to Screening. 11. Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1 (except for permitted contraceptives). 12. If female, be pregnant, breastfeeding, or planning to become pregnant during the study. 13. Have received ciraparantag in any prior clinical study. 14. Have received another investigational drug within 5 half-lives or 30 days, whichever is longer, prior to Day 1. 15. Known allergy to edoxaban, apixaban or rivaroxaban. 16. Have any other condition that, in the opinion of the Investigator, would interfere with a subject's ability to adhere to the protocol, interfere with assessment of the investigational product, or compromise the safety of the subject or the quality of the data.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Frontage Clinical Services
Secaucus, New Jersey, 07094, United States
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ICON Early Phase Services, LLC
San Antonio, Texas, 78209, United States
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Qps-Mra, Llc.
South Miami, Florida, 33143, United States
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