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NCT02770716 · ClinicalTrials.gov registry record · Phase 3
Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1
A Phase 3 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT02770716: Completed Phase 3 study, sponsored by Mallinckrodt.
NCT02770716 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02770716, a Phase 3 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1. Out of every three participants, two will receive terlipressin and one will receive placebo. Assignments will be made randomly.
Primary Outcome
Defined as the percentage of participants with 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart, while on treatment by Day 14 or discharge (on treatment defined as up to 24 hours after the final dose of study drug), per protocol.
Interventions
- OTHER Placebo
- DRUG Terlipressin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2016-07-13 |
| Est. Completion | 2019-07-24 |
| Phase | Phase 3 |
What the finished NCT02770716 record still lists
NCT02770716 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02770716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02770716 about?
NCT02770716 is a clinical study titled "Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1". This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1. Out of every three participants, two will receive terlipressin and one will receive placebo. Assignments will be made randomly.
What is the current status of trial NCT02770716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2016-07-13. Estimated completion is 2019-07-24.
What interventions are being tested in trial NCT02770716?
The interventions under investigation include: Placebo (OTHER), Terlipressin (DRUG).
Who is sponsoring clinical trial NCT02770716?
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 NCT02770716's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 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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