Approval Probability
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Label indication TNKase ® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). TNKase is a tissue plasminogen activator, indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). ( 1 ) FDA label
Tenecteplase · 5 trials · 3 indications
The the modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes. 0 = No symptoms 1. = No significant disability 2. = Slight disability 3. = Moderate disability 4. = Moderately severe disability 5. = Severe disability 6. = Death
Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to -280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.
The primary outcome measure was the number of targeted adverse events, occurring from initial study drug administration through the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for subjects who did not receive open-label, extended-dwell tenecteplase, from initial study administration through the start of Visit 2. Targeted adverse events were defined as intracranial hemorrhage, major bleeding and embolic events, thrombosis, Catheter-related blood stream infection (CRBSIs), and catheter-related complications.
Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications
| Arm | Type | Description |
|---|---|---|
| Tenecteplase | EXPERIMENTAL | Patients in this arm will receive Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds. |
| Placebo | PLACEBO_COMPARATOR | Patients in this arm will receive placebo administered as a single bolus injection over 5 seconds. |
| Placebo + Tenecteplase + Tenecteplase (PTT) | PLACEBO_COMPARATOR | - |
| Tenecteplase + Tenecteplase + Placebo (TTP) | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tenecteplase | BIOLOGICAL | The investigational medicinal product (IMP) for this study is tenecteplase. The recommended total dose for this study is weight-based with 0.25 mg of tenecteplase per kg, not exceeding a maximum dose of 25 mg. A single bolus dose should be administered over 5 seconds based on patient weight. |
| Placebo | OTHER | Placebo is being used as the comparator since a thrombolytic is only FDA-approved in the United States for use out to 3 hours, and the standard of care guidelines support use out to 4.5 hours. |
Inclusion Criteria: * Patient/legally authorized representative has signed the Informed Consent Form * Age \>= 18 years * AIS symptom onset within 4.5 to 24 hours Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the ICA, M1, or...
Tenecteplase is used for thrombolysis, including in stroke patients, and for restoring function in dysfunctional central venous access catheters and dysfunctional hemodialysis catheters. It is a small molecule developed by Roche Holding AG and studied in Phase 3 trials across these indications.
Tenecteplase targets PLAT, also known as plasminogen, an exogenous protein target. By acting on plasminogen, it supports the breakdown of blood clots, which underlies its use in thrombolysis and in clearing dysfunctional catheters.
Tenecteplase is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the company associated with the clinical development program for this small molecule across its thrombolysis and catheter dysfunction indications.
Tenecteplase is in Phase 3 development. It is an investigational agent, and the clinical program includes completed Phase 3 trials. The studies have been randomized, double-blind, and placebo-controlled, with no biomarker-based patient selection.
Tenecteplase has been studied in completed Phase 3 trials including NCT03785678 in stroke patients between 4.5 and 24 hours, NCT00396318 in dysfunctional central venous catheters, and NCT00396253 and NCT00396032 in dysfunctional hemodialysis catheters. Total reported enrollment across these studies is 458 patients in the stroke trial and additional patients in the catheter trials.
Tenecteplase is also known by the name TNKase. Both names refer to the same Roche small molecule that targets PLAT and has been studied in Phase 3 trials for thrombolysis and for restoring function in dysfunctional central venous and hemodialysis catheters.