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NCT03785678 · ClinicalTrials.gov registry record · Phase 3
Tenecteplase in Stroke Patients Between 4.5 and 24 Hours
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 458
- Enrollment target
NCT03785678: Completed Phase 3 study, sponsored by Genentech.
NCT03785678 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 458 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785678, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 458 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS). All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all participants will undergo multimodal CT or MRI at baseline. Only participants with a vessel occlusion (ICA or MCA M1/M2) and penumbral tissue will be randomized. The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90.
Primary Outcome
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
Interventions
- OTHER Placebo
- BIOLOGICAL Tenecteplase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2019-03-02 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 3 |
What the finished NCT03785678 record still lists
NCT03785678 is an interventional study that assigns participants to a tested intervention. The registered 458 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03785678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03785678 about?
NCT03785678 is a clinical study titled "Tenecteplase in Stroke Patients Between 4.5 and 24 Hours". This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS). All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine...
What is the current status of trial NCT03785678?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 458 participants. The study started on 2019-03-02. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT03785678?
The interventions under investigation include: Placebo (OTHER), Tenecteplase (BIOLOGICAL).
Who is sponsoring clinical trial NCT03785678?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03785678's enrollment target sits among peer trials
458 827th of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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