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SRSD107

Clinical trials are investigating SRSD107 to see whether it can help prevent venous thromboembolism, a type of blood clot, after surgery. The main study is looking at safety and how well it works in people having elective total knee replacement, with comparison to enoxaparin.

Table of Contents

Trial overview

The available study of SRSD107 is an interventional trial, which means researchers give a study treatment and then measure the results.[1] It is designed to test whether SRSD107 can prevent venous thromboembolism events and to see how safe it is in this setting.[1]

This study is in Phase 2, a stage that usually looks more closely at whether a treatment works while still watching safety.[1] The trial is focused on people having planned knee replacement surgery on one knee.[1]

Who can participate

The study is for subjects undergoing elective, primary, unilateral total knee arthroplasty (TKA).[1] In simple words, this means people having a planned first-time total knee replacement on one knee.[1]

The trial data do not provide more detailed entry rules, so the main known target group is patients in this surgery setting.[1]

What is being measured

The main outcome is the incidence of total venous thromboembolism (VTE) events from the day of surgery through the venography visit.[1] Incidence means how often the event happens in the study group.[1]

VTE in this trial includes deep vein thrombosis (DVT), which may be silent and found by imaging, or may be symptomatic and confirmed by testing.[1] It also includes pulmonary embolism (PE), both non-fatal and fatal cases, and unexplained death when PE cannot be ruled out.[1]

The planned venography follow-up is 12±2 days after surgery.[1] Venography is an imaging test used to look for clots in the veins.[1]

Study design and comparators

The trial compares SRSD107 with enoxaparin, which is listed in the study data as Clexane 40 mg given under the skin.[1] The intervention list also includes 0.9% sodium chloride solution for injection.[1]

Because the study is interventional, the researchers are directly testing the study treatment against a comparison treatment to judge prevention of clot events after surgery.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 530 participants, which means up to 530 people are expected to join the study.[1]

At this time, the available source data describe one Phase 2 study of SRSD107 in the knee surgery setting.[1]

Patient terms to know

  • Venous thromboembolism means a blood clot in a vein. In this study, it is the main problem researchers want to prevent.[1]
  • Deep vein thrombosis is a clot in a deep vein, often in the leg. It can be found even when there are no symptoms.[1]
  • Pulmonary embolism is a clot that reaches the lungs. The study counts both non-fatal and fatal cases.[1]
  • Total knee arthroplasty means total knee replacement. The study is for people having this planned operation on one knee.[1]
  • Venography is a scan used to check the veins for clots. In this trial, it is done about 12 days after surgery.[1]
  • Comparator means the treatment used for comparison. Here, SRSD107 is compared with enoxaparin.[1]
Trial ID Phase Condition studied Status Enrollment
2024-519688-16-00 Phase 2 Venous thromboembolism after elective primary unilateral total knee arthroplasty Authorised 530

FAQ

  • What is being studied in SRSD107 clinical trials? The trial is studying whether SRSD107 can prevent venous thromboembolism events after surgery. It is also checking how safe it is in this setting.
  • Who can take part in the main SRSD107 trial? The study is for people having elective, primary, unilateral total knee arthroplasty. This means planned first-time knee replacement on one knee.
  • What phase is the SRSD107 trial? The trial is in Phase 2. Phase 2 studies usually look more closely at whether a treatment works and continue to monitor safety.
  • What condition is the trial focused on? The trial focuses on venous thromboembolism, often called VTE. This includes deep vein thrombosis and pulmonary embolism.
  • What is the main outcome being measured? The main outcome is the total number of VTE events from surgery until the follow-up venography visit. The study also checks for deep vein thrombosis, pulmonary embolism, and unexplained death when PE cannot be ruled out.

Ongoing Clinical Trials on SRSD107

  • Comparison of SRSD107 and enoxaparin to prevent blood clots in adults undergoing knee replacement surgery

    Recruiting

    2 1 1
    Investigated drugs:
    Bulgaria Czechia Hungary Latvia Lithuania Poland

Glossary

  • Venous thromboembolism (VTE): A blood clot that forms in a vein. It includes deep vein thrombosis and pulmonary embolism.
  • Deep vein thrombosis (DVT): A blood clot in a deep vein, usually in the leg.
  • Pulmonary embolism (PE): A blood clot that travels to the lungs. It can be serious and needs urgent care.
  • Elective surgery: A planned operation, not an emergency procedure.
  • Primary unilateral total knee arthroplasty (TKA): A first-time total knee replacement on one knee.
  • Phase 2: A stage of clinical research that looks at how well a treatment works and continues safety checks.
  • Interventional study: A study where participants receive a treatment or comparison treatment so researchers can measure results.
  • Venography: An imaging test used to look for blood clots in the veins.
  • Enrollment: The number of people planned to join a study.
  • Comparator: A treatment used for comparison in a trial, so researchers can see how the study drug performs.

References