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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: Completed Phase 3 study, sponsored by Grifols Therapeutics.
NCT03451292 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 410 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to one-year transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, an
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 |
What the finished NCT03451292 record still lists
NCT03451292 is an interventional study that assigns participants to a tested intervention. The registered 410 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 (47% lower).
The record links to 0 conditions, and to 2 interventions - of which SMT is the first listed.
NCT03451292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03451292's enrollment target sits among peer trials
410 909th of 2000 higher than 1,090 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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