2023-503719-13-00招募中3 期
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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 282
- 试验地点
- 19
- 主要终点
- Number of clinically relevant postoperative oral bleeding episodes (including clinically relevant orofacial hematomas) in all subjects
研究概览
简要总结
To assess and compare the efficacy of Tranexamic Acid Oral Solution 5% with placebo to reduce clinically relevant postoperative oral bleeding (including clinically relevant orofacial hematomas) in subjects treated with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) and following a single or multiple tooth extraction(s) in all subjects.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Provide their signed study informed consent to participate.
- •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 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
- •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 anticoagulant (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.
- •Subjects taking VKAs or DOACs can be enrolled if these are prescribed and used according to the approved product label
- •Scheduled to undergo a single or multiple tooth extraction
- •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
排除标准
- •Any coagulation disorders requiring TXA.
- •Use of hormonal methods of birth control that increase the risk of thrombosis (e.g., estrogen-containing contraceptives). Refer to Table 4 in protocol Section 8.2.11 for further information on acceptable and unacceptable birth control methods.
- •Requires tooth extraction for orthodontic reason
- •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 II, III and 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.
- •Women with intended pregnancy or breast-feeding
- •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
- •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]).
- •Severe uncontrolled arterial hypertension, e.g., > 200 mmHg systolic or > 110 mmHg diastolic blood pressure at two consecutive readings
- •Subjects who are found positive to human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) serological tests.
结局指标
主要结局
Number of clinically relevant postoperative oral bleeding episodes (including clinically relevant orofacial hematomas) in all subjects
Number of clinically relevant postoperative oral bleeding episodes (including clinically relevant orofacial hematomas) in all subjects
次要结局
- Number of not clinically relevant postoperative oral bleeding episodes (including not clinically relevant orofacial hematomas) in all subjects.
- Number of delayed postoperative oral bleeding episodes, both clinically relevant and not clinically relevant, in all subjects.
- Number of early (less than 24 h post-tooth extraction) postoperative oral bleeding episodes, both clinically relevant and not clinically relevant, in all subjects
- Perioperative and immediate post-operative (procedural bleeding) duration (min, all types of oral bleeding).
- Medication Acceptability Questionnaire (MAQ) for Tranexamic Acid Oral Solution 5% use completed in all subjects
研究者
Christophe Lyssens
Scientific
Hyloris Developments
研究点 (19)
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