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NCT03963895 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis
A Phase 2 study, sponsored by Aronora.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03963895: Completed Phase 2 study, sponsored by Aronora.
NCT03963895 is a Phase 2 study that has completed, run by Aronora. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03963895, a Phase 2 study, has completed, sponsored by Aronora.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB002 (E-WE thrombin) or placebo (at a ratio of 2:1 active: placebo).
Primary Outcome
TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Interventions
- DRUG placebo
- DRUG AB002 Dose 1
- DRUG AB002 Dose 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-07-03 |
| Est. Completion | 2020-12-29 |
| Phase | Phase 2 |
What the finished NCT03963895 record still lists
NCT03963895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT03963895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03963895 about?
NCT03963895 is a clinical study titled "Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis". This study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB002 (E-WE thrombin) or placebo (at a ratio ...
What is the current status of trial NCT03963895?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2019-07-03. Estimated completion is 2020-12-29.
What interventions are being tested in trial NCT03963895?
The interventions under investigation include: placebo (DRUG), AB002 Dose 1 (DRUG), AB002 Dose 2 (DRUG).
Who is sponsoring clinical trial NCT03963895?
This trial is sponsored by Aronora, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03963895's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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