deltatrials
Unknown PHASE3 INTERVENTIONAL 2-arm NCT06143787

Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Study to Compare the Efficacy, Acceptability, and Safety of Tranexamic Acid Oral Solution 5% With Placebo in the Prevention of Clinically Relevant Bleeding Events in Subjects Treated With Direct Oral Anticoagulants or Vitamin K Antagonists and Undergoing a Single or Multiple Tooth Extraction.

Sponsor: Hyloris Developments

Interventions Tranexamic acid
Updated 7 times since 2023 Last updated: Jul 31, 2024 Started: Nov 7, 2023 Primary completion: Dec 27, 2024 Completion: Dec 27, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Bleeding From Teeth and Bleeding Prophylaxis and is currently ongoing. Hyloris Developments leads this study, which shows 7 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2023 – ~Jun 2024 · 6 months · monthly snapshotRecruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotRecruiting~Sep 2025 – ~Jan 2026 · 4 months · monthly snapshotRecruiting~Jan 2026 – present · 7 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE3

    Status: RecruitingUnknown

  2. Sep 2025 — Jan 2026 [monthly]

    Recruiting PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Recruiting PHASE3

  4. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE3

Show 2 earlier versions
  1. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  2. Dec 2023 — Jun 2024 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hyloris Developments
Data source: Hyloris Developments

For direct contact, visit the study record on ClinicalTrials.gov .