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NCT01143246 · ClinicalTrials.gov registry record · Phase 3
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
A Phase 3 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 196
- Enrollment target
NCT01143246: Completed Phase 3 study, sponsored by Mallinckrodt.
NCT01143246 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 196 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143246, a Phase 3 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 196 participants
- Enrollment target
Study Summary
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
Primary Outcome
Confirmed HRS Reversal: The percentage of participants with two serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 48 hours apart, on treatment, and without intervening renal replacement therapy or liver transplant.
Interventions
- DRUG Placebo
- DRUG Terlipressin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2010-10-11 |
| Est. Completion | 2013-05-10 |
| Phase | Phase 3 |
What the finished NCT01143246 record still lists
NCT01143246 is an interventional study that assigns participants to a tested intervention. The registered 196 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 (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01143246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01143246 about?
NCT01143246 is a clinical study titled "A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin". This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
What is the current status of trial NCT01143246?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2010-10-11. Estimated completion is 2013-05-10.
What interventions are being tested in trial NCT01143246?
The interventions under investigation include: Placebo (DRUG), Terlipressin (DRUG).
Who is sponsoring clinical trial NCT01143246?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01143246's enrollment target sits among peer trials
196 1390th of 2000 higher than 608 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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