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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 is a Phase 3 study that was terminated before completion, run by Instituto Grifols, S.A.. The registered enrollment target is 274 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03702920
The ClinicalTrials.gov registry entry for NCT03702920 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 274 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Instituto Grifols, S.A., which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Medical Treatment is the first listed.
NCT03702920 reports 0 study locations.
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.
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