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NCT03451292 · ClinicalTrials.gov registry record · Phase 3
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
A Phase 3 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
NCT03451292 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 410 participants.
The verdict
NCT03451292, a Phase 3 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
Study Summary
This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in participants with decompensated cirrhosis and ascites. The study population will consist of participants being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.
Interventions
- OTHER SMT
- DRUG Albutein 20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2024-05-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03451292
The ClinicalTrials.gov registry entry for NCT03451292 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SMT is the first listed.
NCT03451292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03451292 about?
NCT03451292 is a clinical study titled "Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites". This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in participants with decompensated cirrhosis and ascites. The study population will consis...
What is the current status of trial NCT03451292?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2018-07-24. Estimated completion is 2024-05-21.
What interventions are being tested in trial NCT03451292?
The interventions under investigation include: SMT (OTHER), Albutein 20% (DRUG).
Who is sponsoring clinical trial NCT03451292?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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