Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
The combination of rFVIIa (recombinant activated Factor VIIa) and tranexamic acid (TXA) is a therapeutic approach used primarily in patients with bleeding disorders or those at risk of significant bleeding during surgical procedures. This combination works by enhancing hemostasis through complementary mechanisms - rFVIIa activates the coagulation cascade while tranexamic acid prevents fibrinolysis (the breakdown of blood clots). According to the research, this combination has shown effectiveness in several clinical scenarios: 1. For patients with severe Factor XI deficiency undergoing urological procedures[1][3] 2. For hemophilia patients with inhibitors[2] 3. For controlling postoperative bleeding after fondaparinux administration[5] 4. For prophylaxis of bleeding episodes in dental procedures[6] The combination appears particularly valuable because it allows for lower doses of rFVIIa when used with tranexamic acid, potentially reducing risks while maintaining efficacy. Studies have shown that this combination can normalize clot stability in hemophilia patients with inhibitors compared to healthy controls[2]. ## Clinical Applications **Factor XI Deficiency**: A single low dose of rFVIIa (10-15 mcg/kg) combined with tranexamic acid (1g four times daily for 7-10 days) has been shown to be effective for patients with severe Factor XI deficiency undergoing urological procedures[1][3]. **Hemophilia with Inhibitors**: The combination of bypassing agents like rFVIIa with tranexamic acid has demonstrated improved hemostasis without increasing thrombotic risk[2]. **Postoperative Bleeding**: Single doses of rFVIIa (90 μg/kg) and tranexamic acid (15 mg/kg) have been effective in controlling severe postoperative bleeding, particularly after fondaparinux administration[5]. ## Safety Profile The available research indicates that this combination appears to be safe, with no reported clinical or laboratory signs of thromboembolic events, disseminated intravascular coagulation, or hypercoagulability in the studied populations[2]. This is particularly noteworthy as both agents individually have potential prothrombotic effects. The sequential administration or combination of tranexamic acid and rFVIIa may be considered to enhance efficacy in certain clinical scenarios[7].
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on Recombinant Factor VIIa and Tranexamic Acid Combination.