Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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, or the breakdown of blood clots, and for restoring function in dysfunctional hemodialysis catheters and dysfunctional central venous access catheters. It is being investigated in Phase 3 clinical trials for these indications.
Tenecteplase is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting Phase 3 clinical trials to evaluate the drug for thrombolysis and catheter dysfunction.
Tenecteplase is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trials for thrombolysis and catheter dysfunction have been completed.
Tenecteplase has been studied in four Phase 3 clinical trials. These include NCT00395876 and NCT00396318 for dysfunctional central venous access catheters, NCT00396253 for dysfunctional hemodialysis catheters, and NCT03785678 for thrombolysis in stroke patients. All trials have been completed.
Yes, Tenecteplase is classified as a small molecule therapeutic. It is being developed by Roche Holding AG for use in nephrology and thrombolysis indications.