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NCT03702920 · ClinicalTrials.gov registry record · Phase 3
Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%
A Phase 3 study, sponsored by Instituto Grifols, S.A..
- Terminated
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
NCT03702920: Clinical Trial Phase 3 study, sponsored by Instituto Grifols, S.A..
NCT03702920 is a Phase 3 study that was terminated before completion, run by Instituto Grifols, S.A.. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03702920, a Phase 3 study, was terminated before completion, sponsored by Instituto Grifols, S.A..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
Study Summary
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF. Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period. The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution. The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards. The Follow-up Period for subjects in both groups will be 90 days.
Primary Outcome
Time to 90-day overall survival was to be calculated as \[(date of death) - randomization date\] for those participants who died without having liver transplant on or prior to 90 days. Participants who did not die, or had a liver transplant before death were to have their time to event censored at the earlier of date of last contact, liver transplant date or cut-off date. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants wi
Interventions
- OTHER Standard Medical Treatment
- BIOLOGICAL SMT + PE-A 5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 3 |
Why NCT03702920 stopped before completion
NCT03702920 is an interventional study that assigns participants to a tested intervention. The registered 274 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Medical Treatment is the first listed.
NCT03702920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03702920 about?
NCT03702920 is a clinical study titled "Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%". This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Ca...
What is the current status of trial NCT03702920?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2019-06-17. Estimated completion is 2025-04-14.
What interventions are being tested in trial NCT03702920?
The interventions under investigation include: Standard Medical Treatment (OTHER), SMT + PE-A 5% (BIOLOGICAL).
Who is sponsoring clinical trial NCT03702920?
This trial is sponsored by Instituto Grifols, S.A., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03702920's enrollment target sits among peer trials
274 1207th of 2000 higher than 788 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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