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NCT02878603 · ClinicalTrials.gov registry record · Phase 3
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
NCT02878603: Completed Phase 3 study, sponsored by Sanofi.
NCT02878603 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02878603, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
Study Summary
The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).
Primary Outcome
aTTP-related events were defined as: aTTP-related death, recurrence of aTTP (defined as recurrent thrombocytopenia requiring initiation of daily PE) or at least one major thromboembolic event (e.g., myocardial infarction, cerebrovascular accident, pulmonary embolism, or deep venous thrombosis). Percentage of participants with at least one aTTP-related events during the study were reported in this outcome measure.
Interventions
- OTHER Standard of Care
- BIOLOGICAL Caplacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2016-10-06 |
| Est. Completion | 2020-10-23 |
| Phase | Phase 3 |
What the finished NCT02878603 record still lists
NCT02878603 is an interventional study that assigns participants to a tested intervention. The registered 104 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 (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT02878603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02878603 about?
NCT02878603 is a clinical study titled "Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)". The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).
What is the current status of trial NCT02878603?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2016-10-06. Estimated completion is 2020-10-23.
What interventions are being tested in trial NCT02878603?
The interventions under investigation include: Standard of Care (OTHER), Caplacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02878603?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02878603's enrollment target sits among peer trials
104 1671st of 2000 higher than 327 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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