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

NCT06143787 | Unknown Phase 3 DMC FDA Drug

• 2 other identifiers: HYL-P004-0032023-503719-13-00
• Study Type: interventional
• Target: 280
• Locations: 5 countries
• Sites: 19

Brief Summary

The purpose of this study is to assess the effect of Tranexamic Acid Oral Solution 5% in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction.

Conditions

Bleeding From Teeth; Bleeding Prophylaxis

Keywords

bleeding teeth; Tranexamic Acid; Oral Solution; Tranexamic Acid Oral Solution 5%

Outcome Measures

Primary Outcomes (1)

• Number of clinically relevant postoperative oral bleeding episodes

  Number of clinically relevant postoperative oral bleeding episodes (including clinically relevant orofacial hematomas)

  7 days

Secondary Outcomes (5)

• Number of postoperative oral bleeding episodes

  7 days

• Number of delayed postoperative oral bleeding episodes

  7 days

• Number of early postoperative oral bleeding episodes

  7 days

• Perioperative and immediate post-operative duration

  7 days

• Medication Acceptability Questionnaire (MAQ) completed

  7 days

Study Arms (2)

Treatment (T1)

PLACEBO COMPARATOR

Standard hemostatic measures + Placebo matching with Tranexamic Acid Oral Solution 5%

Drug: Tranexamic acid

Treatment (T2)

EXPERIMENTAL

Standard hemostatic measures + Tranexamic Acid Oral Solution 5%

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

7 days Oral rinsing following tooth extraction

Also known as: Tranexamic Acid Oral Solution 5%

Treatment (T1); Treatment (T2)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide their signed study informed consent to participate.
• Male or female ≥ 18 years of age at screening.
• Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2, inclusively and body weight ≥ 50 kg.
• Treated regularly for ≥ 3 months with direct oral anticoagu19lant (e.g., edoxaban, apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol, warfarin, etc.).
• Subjects on VKAs can be enrolled if the subject's International Normalized Ratio (INR) at screening, but not more than 5 days before the dental extraction procedure is within the range of 2.0-3.5.
• Subjects taking VKAs or DOACs can be enrolled if these are prescribed and used according to the approved product label.
• Accepting to not discontinue his/her anticoagulant medication on the day of the extraction.
• Scheduled to undergo a single or multiple (≤ 5 teeth, single-rooted, double-rooted, or multi-rooted, maximum 3 multi-rooted teeth and 2 different extraction sites) tooth extraction. Subjects with a single extraction site may have up to a maximum of 5 adjacent teeth extracted at the site, and subjects with two extraction sites may have up to a maximum of 3 adjacent extracted teeth at one site and 2 adjacent extracted teeth at the other site.
• Considered as reasonably healthy to follow the study procedures as documented by the medical history, physical examination, and vital sign assessments.
• Subjects with a platelet count of 100,000-500,000 (inclusive) platelets per microliter.
• Subject with hemoglobin ≥ 12.0 g/dL (male) or ≥ 11.0 g/dL (female).
• Willing to avoid alcohol consumption for the duration of the study.
• Willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent.
• Negative pregnancy test in females of childbearing potential at Screening and Day 1 visit.
• Women must be post-menopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or willing to use highly effective method of birth control which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (refer to Table 4 in protocol Section 8.2.11 for further information on acceptable and unacceptable birth control methods). The Investigator is responsible for determining whether the subject has adequate birth control for study participation.

You may not qualify if:

• Any coagulation disorders requiring TXA.
• Wisdom teeth extraction.
• History of severe allergy or allergic reactions or hypersensitivity to the study drug or any component of its formulations or related drugs or heparin
• Subjects with type IV periodontitis (as per American Dental Association Classification) (see Appendix 1).
• History of subarachnoid hemorrhage.
• Active intravascular clotting (defined as a history of thrombosis within the past 3 months).
• Blood in the urine (macroscopic hematuria) at Screening.
• Renal function test result of estimated glomerular filtration rate ≤ 15 mL/min/1.73 m² at Screening.
• Any ongoing or planned dual anti-platelet treatment for the duration of subject's participation in the study (any 2 of the following: aspirin, dipyridamole, or any thienopyridine, i.e., clopidogrel, prasugrel, ticlopidine, ticagrelor). However, subjects receiving a very low dose aspirin (≤ 160 mg) may be enrolled.
• Any ongoing or planned oncological treatment for the duration of subject's participation in the study.
• Any immunocompromising condition.
• Use of any recreational drugs or history of drug addiction.
• Positive alcohol breath test at Screening and Day 1.
• Participating in any other clinical study or has received treatment with any investigational drug or device within 3 months prior to screening.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications (including but not limited to diseases such as uncontrolled diabetes, any haemato-oncological condition \[e.g., leukemia\], any congenital hematological condition \[e.g., hemophilia\]).

Sponsors & Collaborators

• Hyloris Developments: lead

Study Sites (19)

Loma Linda University School of Dentistry

Loma Linda, California, 92350, United States

RECRUITING

Stamford Therapeutics Consortium

Stamford, Connecticut, 06901, United States

NOT YET RECRUITING

JBR Clinical Research (CenExel)

Millcreek, Utah, 84107, United States

WITHDRAWN

Roseman University of Health Sciences, College of Dental Medicine

South Jordan, Utah, 84107, United States

RECRUITING

Clinical Hospital Center Rijeka, Dental clinic

Rijeka, 51000, Croatia

RECRUITING

University Hospital of Split Department of Oral surgery

Split, 21000, Croatia

NOT YET RECRUITING

Dental Clinic Zagreb

Zagreb, 10000, Croatia

RECRUITING

University hospital Dubrava Department of oral surgery

Zagreb, 10000, Croatia

NOT YET RECRUITING

Semmelweis Egyetem, Fogorvostudományi Kar, Arc-Állcsont-Szájsebészeti És Fogászati Klinika

Budapest, 1085, Hungary

RECRUITING

SZTE SZAKK Arc-, Állcsont- és Szájsebészeti Klinika

Szeged, 6722, Hungary

NOT YET RECRUITING

Arc-, Állcsont-, Szájsebészeti Osztály

Veszprém, 8200, Hungary

NOT YET RECRUITING

"Dr. Carol Davila" Central Military Emergency University Hospital Bucharest

Bucharest, 010825, Romania

RECRUITING

Trident Clinic

Bucharest, 050533, Romania

RECRUITING

SCJU Craiova

Craiova, 200642, Romania

RECRUITING

Medicine and Healthcare Science Faculty of Barcelona University (Campus Bellvitge

Barcelona, 08907, Spain

NOT YET RECRUITING

Puerta del Mar University Hospital

Cadiz, 11009, Spain

RECRUITING

Jerez Center Health Center

Jerez de la Frontera, 11403, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Institute of Biotechnology of Seville (IBIS)

Seville, 41009, Spain

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Todd Bertoch, Dr.

  JBR Clinical Research (CenExcel)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Lyssens

CONTACT

+3243460207; clinical@hyloris.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, multi-center, placebo-controlled, parallel-group

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 22, 2023
• Study Start: November 7, 2023
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: August 1, 2024

Record last verified: 2023-11

Locations

US (4); CR (4); ES (5); RO (3); HU (3)